HealthyPhase 1NCT07838987
A Clinical Trial to Evaluate MK-4208/Embibatinib in Healthy Adult Participants (MK-4208-001/Embibatinib-1014)
A Phase 1 study testing Embibatinib, Rabeprazole and Midazolam in people with Healthy, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
The goal of the study is to learn what happens to different doses and forms of Embibatinib in a healthy person's body over time. Researchers will compare what happens to different doses and forms of Embibatinib in a person's body over time when given with or without food, or with or without other medications. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Embibatinib, Rabeprazole and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2023to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has body weight ≥48 kg (105.6 lbs) and body mass index within the range of 18.5 to 32 kg/m^2 (inclusive)
- Is in good health
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has history or clinical manifestation of any metabolic, allergic, autoimmune, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, ocular, respiratory, endocrine, or psychiatric disorder, or any condition that would affect drug absorption, distribution, metabolism, or excretion (eg, stomach or intestinal surgery, or gallbladder removal/cholecystectomy). Uncomplicated appendectomy and hernia repair will be allowed.
- Has history of QT prolongation syndrome, unexplained syncope, family history of sudden death, atrial fibrillation, malignant tumor, mental disorder, or any major disease
- Has positive screening test for Hepatitis B surface antigen, anti-Hepatitis C virus antibodies, or anti-Human immunodeficiency virus (HIV) 1 and 2 antibodies
- Has any known history of bleeding, or prothrombin time (Embibatinib + Probe Substrate Cocktail-2 arm only)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Embibatinib, the Effects of Food, Acid-Reducing Agents, and Drug-Drug Interactions, and the Relative Bioavailability of New Tablet Formulations of Embibatinib.
The goal of the study is to learn what happens to different doses and forms of Embibatinib in a healthy person's body over time. Researchers will compare what happens to different doses and forms of Embibatinib in a person's body over time when given with or without food, or with or without other medications.
The goal of the study is to learn:
- What happens to different doses of Embibatinib in a person's body over time when it is given with or without food, or with or without other medications.
- About the safety of Embibatinib and if people tolerate it
Read the detailed description
Per protocol, participants will be randomized in Cohort 7 to the sequence in which they receive two Embibatinib formulations. All other cohorts will be non-randomized.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbibatinibDrug
Also called MK-4208, HS-10382
Oral Tablet
RabeprazoleDrug
The United States commercially marketed 20 mg oral tablet formulation is being used in this trial.
MidazolamDrug
2 mg oral syrup formulation administered as part of the probe substrate cocktail-1 and probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial.
DigoxinDrug
0.25 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.
PravastatinDrug
40 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.
MontelukastDrug
10 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.
OmeprazoleDrug
40 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.
ItraconazoleDrug
The United States commercially marketed 200 mg oral capsule formulation is being used in this trial.
WarfarinDrug
5 mg oral tablet formulation administered as part of the probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial.
RosuvastatinDrug
10 mg oral tablet formulation administered as part of the probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial.
BosentanDrug
The Europe commercially marketed 125 mg oral tablet formulation is being used in this trial.
QuinidineDrug
The United States commercially marketed 300 mg oral tablet formulation is being used in this trial.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Single Ascending Dose (SAD) Escalation of Embibatinib Dose Level 1 | Experimental | Participants receive a single oral dose of Embibatinib Dose Level 1 under fasted conditions on Day 1. Receives: Drug: Embibatinib |
| Cohort 2: SAD Escalation of Embibatinib Dose Level 2 | Experimental | Participants receive a single oral dose of Embibatinib Dose Level 2 under fasted conditions on Day 1. Receives: Drug: Embibatinib |
| Cohort 3: SAD Escalation of Embibatinib Dose Level 3 and Food Effect | Experimental | On Period 1 Day 1, participants receive a single oral dose of Embibatinib Dose Level 3 under fasted conditions. On Period 2 Day 1, participants receive Embibatinib Dose Level 3 after a high-fat meal. Receives: Drug: Embibatinib |
| Cohort 4: SAD Escalation of Embibatinib Dose Level 4 | Experimental | Participants receive a single oral dose of Embibatinib Dose Level 4 under fasted conditions on Day 1. Receives: Drug: Embibatinib |
| Cohort 5: SAD Escalation of Embibatinib Dose Level 5 | Experimental | Participants receive a single oral dose of Embibatinib Dose Level 5 under fasted conditions on Day 1. Receives: Drug: Embibatinib |
| Cohort 6: SAD Escalation of Embibatinib Dose Level 7 | Experimental | Participants receive a single oral dose of Embibatinib Dose Level 7 under fasted conditions on Day 1. Receives: Drug: Embibatinib |
| Cohort 7: Embibatinib Formulations with Rabeprazole 20 mg | Experimental | Participants in Cohort 7 are randomized to receive Embibatinib Formulation 1 or Formulation 2 at Dose Level 5 on Day 1. On Day 7, participants receive Embibatinib Formulation 2 or Formulation 1 at Dose Level 5. Participants also receive Rabeprazole 20 mg once daily on Days 10-13. On Day 14, participants will co-administer a single oral dose of Rabeprazole 20 mg with Embibatinib Formulation 1 Dose Level 5 at the same time. All participants receive treatment under fasted conditions. Receives: Drug: Embibatinib; Drug: Rabeprazole |
| Cohort 8: Embibatinib + Probe Substrate Cocktail-1 | Experimental | Per protocol, the probe substrate cocktail-1 consists of midazolam 2 mg, digoxin 0.25 mg, pravastatin 40 mg, montelukast 10 mg, and omeprazole 40 mg. On Day 1, participants receive a single oral dose of the probe substrate cocktail-1 under fasted conditions. On Day 5, participants receive a single oral dose of Embibatinib Dose Level 4 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. On Day 9, participants receive a single oral dose of Embibatinib Dose Level 7 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. Receives: Drug: Embibatinib; Drug: Midazolam; Drug: Digoxin; Drug: Pravastatin; Drug: Montelukast; Drug: Omeprazole |
| Cohort 9: Embibatinib Dose Level 5 + Rabeprazole 20 mg | Experimental | Participants receive a single oral dose of Embibatinib Dose Level 5 on Day 1 under fasted conditions. On Days 4-7 participants will receive Rabeprazole 20 mg once daily under fasted conditions. On Day 8, under fasted conditions, participants co-administer a single oral dose of Embibatinib Dose Level 5 with a single oral dose of Rabeprazole 20 mg taken at the same time under fasted conditions. Receives: Drug: Embibatinib; Drug: Rabeprazole |
| Cohort 10: SAD Escalation of Embibatinib Dose Level 8 | Experimental | Participants receive a single oral dose of Embibatinib Dose Level 8 under fasted conditions on Day 1. Receives: Drug: Embibatinib |
| Cohort 11: SAD Escalation of Embibatinib Dose Level 9 | Experimental | Participants receive a single oral dose of Embibatinib Dose Level 9 under fasted conditions on Day 1. Receives: Drug: Embibatinib |
| Cohort 12: Embibatinib Dose Level 3 + Itraconazole 200 mg | Experimental | Participants receive a single oral dose of Embibatinib at Dose Level 3 under nonfasted conditions on Day 1. On Day 8, participants will receive Itraconazole 200 mg twice daily after a standardized breakfast and evening snack. On Days 9-11, participants will take a single oral dose of Itraconazole 200 mg after a standardized meal. On Day 12, participants will take a single dose of Itraconazole 200mg after a standardized meal followed by Embibatinib Dose Level 3 taken an hour later. Participants will continue taking a single oral dose of Itraconazole 200 mg once daily after a standardized meal on Days 13-15. Receives: Drug: Embibatinib; Drug: Itraconazole |
| Cohort 13: Multiple Ascending Dose (MAD) Escalation of Embibatinib Dose Level 4 | Experimental | Participants receive an oral dose of Embibatinib Dose Level 4 once daily from Day 1 to Day 13 under fasted conditions. Receives: Drug: Embibatinib |
| Cohort 14: Embibatinib Dose Level 5 + Probe Substrate Cocktail-2 | Experimental | Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of Embibatinib Dose Level 5 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with Embibatinib Dose Level 5 taken at the same time under fasted conditions. On Days 17-21 participants receive Embibatinib Dose Level 5 as a single oral dose once daily under fasted conditions. Receives: Drug: Embibatinib; Drug: Midazolam; Drug: Warfarin; Drug: Rosuvastatin |
| Cohort 15: Embibatinib Dose Level 8 + Probe Substrate Cocktail-2 | Experimental | Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of Embibatinib Dose Level 8 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with Embibatinib Dose Level 8 taken at the same time under fasted conditions. On Days 17-21 participants receive Embibatinib Dose Level 8 as a single oral dose once daily under fasted conditions. Receives: Drug: Embibatinib; Drug: Midazolam; Drug: Warfarin; Drug: Rosuvastatin |
| Cohort 16: Food Effect on Embibatinib Dose Level 8 Formulations with Rabeprazole 20 mg | Experimental | On Period 1 Day 1, participants receive a single oral dose of Embibatinib Formulation 3 Dose Level 8 (DL8). On Period 1 Day 7, participants receive a single oral dose of Embibatinib Formulation 4 DL8. On Period 1 Day 13, participants receive a single oral dose of Embibatinib Formulation 5 DL8. On Period 1 Day 19, participants receive a single oral dose of Embibatinib Formulation 6 DL8. All Period 1 treatments are administered under fasted conditions. Per protocol, following Period 1, one formulation is selected for Period 2. On Period 2 Day 1, participants receive a single oral dose of the selected Embibatinib formulation DL8 after a high-fat meal. On Period 2 Days 7-10, participants receive rabeprazole 20 mg once daily under fasted conditions. On Period 2 Day 11, participants receive the selected formulation of Embibatinib DL8 as a single oral dose, co-administered with the single oral dose of Rabeprazole 20 mg taken at the same time under fasted conditions. Receives: Drug: Embibatinib; Drug: Rabeprazole |
| Cohort 17: Food Effect on Embibatinib Dose Level 8 Selected Formulation with Rabeprazole 20 mg | Experimental | Per protocol, a formulation from Cohort 16 Period 1, different from the formulation selected for Cohort 16 Period 2, may be selected to evaluate the effects of food and rabeprazole 20 mg. On Day 1, participants receive a single oral dose of the selected formulation of Embibatinib Dose Level 8 under fasted conditions. On Day 7, participants receive a single oral dose of the selected formulation of Embibatinib Dose Level 8 after a high-fat meal. On Days 13-16, participants receive a single oral dose of rabeprazole 20 mg once daily. On Day 17, participants receive a single oral dose of the selected formulation of Embibatinib Dose Level 8 co-administered with a single oral dose of rabeprazole 20 mg taken at the same time under fasted conditions. Receives: Drug: Embibatinib; Drug: Rabeprazole |
| Cohort 18: Embibatinib Dose Level 8 + Bosentan 125 mg | Experimental | On Day 1, participants receive a single oral dose of Embibatinib Dose Level 8 under fasted conditions. Beginning on Day 8, participants receive an oral dose of Bosentan 125 mg twice daily. On Day 15, participants receive Embibatinib Dose Level 8 as a single oral dose co-administered with the morning dose of Bosentan 125 mg taken at the same time under fasted conditions; participants then receive the second daily dose of Bosentan 125 mg in the evening. Participants continue taking Bosentan 125 mg twice daily on Days 16-18. Receives: Drug: Embibatinib; Drug: Bosentan |
| Cohort 19: Embibatinib Dose Level 6 + Quinidine 300 mg | Experimental | Participants receive a single oral dose of Embibatinib Dose Level 6 on Day 1 under fasted conditions. Beginning on Day 6, participants receive an oral dose of Quinidine 300 mg three times daily. On Day 8, participants receive Embibatinib Dose Level 6 as a single oral dose co-administered with the morning final dose of Quinidine 300 mg taken at the same time under fasted conditions. Receives: Drug: Embibatinib; Drug: Quinidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience a Treatment Emergent Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience a treatment emergent AE will be reported.
Measured: Up to approximately 102 days
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 102 days
Number of Participants with Clinically Significant Abnormalities in Systolic Blood Pressure
Blood pressure will be measured after the participant has been at rest in a supine position for at least 10 minutes. Blood pressure and pulse measurements will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available. Blood pressure measurements will be carried out before blood sample collections or at least 30 minutes after any blood draws.
Measured: up to approximately 102 days
Number of Participants with Clinically Significant Abnormalities in Diastolic Blood Pressure
Blood pressure will be measured after the participant has been at rest in a supine position for at least 10 minutes. Blood pressure and pulse measurements will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available. Blood pressure measurements will be carried out before blood sample collections or at least 30 minutes after any blood draws.
Measured: up to approximately 102 days
Number of Participants with Abnormal Clinical Hematology Test Results Reported as Adverse Events
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal hematology-related AEs will be reported.
Measured: up to approximately 102 days
Number of Participants with Abnormal Clinical Chemistry Test Results Reported as Adverse Events
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal chemistry-related AEs will be reported.
Measured: up to approximately 102 days
Number of Participants with Abnormal Urinalysis Results Reported as Adverse Events
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal urinalysis-related AEs will be reported.
Measured: up to approximately 102 days
Number of Participants with Clinically Significant Abnormalities in 12-Lead (ECG) Findings
During the 12-lead ECG collection participants will be instructed to lie supine for at least 10 minutes prior to ECG collection. During the collection, participants should be in a quiet setting, without distractions, and should refrain from talking or moving their arms or legs. All ECG acquisitions will be carried out before any blood sample collections or at least 30 minutes after any blood draws.
Measured: up to approximately 102 days
Area Under the Concentration versus Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of Embibatinib in Plasma
Blood samples will be collected to determine the AUC0-Last of Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Area Under the Concentration versus Time Curve Extrapolated to Infinite Time (AUC0-Inf) of Embibatinib in Plasma
Blood samples will be collected to determine the AUC0-inf of Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Area Under the Concentration versus Time Curve Over the Dosing Interval (AUCtau) of Embibatinib in Plasma
Blood samples will be collected to determine the AUCtau of Embibatinib.
Measured: Pre-dose and at designated time points up to 24 hours post dose
Maximum Observed Concentration of Drug (Cmax) of Embibatinib in Plasma
Blood samples will be collected to determine the Cmax of Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Apparent Terminal Elimination Half-Life (t1/2) of Embibatinib in Plasma
Blood samples will be collected to determine the t1/2 of Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Time of Maximum Observed Concentration of Drug (Tmax) of Embibatinib in Plasma
Blood samples will be collected to determine the Tmax of Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Secondary outcomes (40)
AUC0-last of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Blood samples will be collected to determine the AUC0-Last of Embibatinib under fed versus fasted conditions.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Blood samples will be collected to determine the AUC0-inf of Embibatinib under fed versus fasted conditions.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Blood samples will be collected to determine the Cmax of Embibatinib under fed versus fasted conditions.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Tmax of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Blood samples will be collected to determine the Tmax of Embibatinib under fed versus fasted conditions.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Embibatinib Formulations in Plasma
Blood samples will be collected to determine the AUC0-Last of Embibatinib formulations.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib Formulations in Plasma
Blood samples will be collected to determine the AUC0-Inf of Embibatinib formulations.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib Formulations in Plasma
Blood samples will be collected to determine the Cmax of Embibatinib formulations.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Embibatinib in Plasma Administered With or Without an Acid-Reducing Agent
Blood samples will be collected to determine the AUC0-Last of Embibatinib administered with or without an acid-reducing agent.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib in Plasma Administered With or Without an Acid-Reducing Agent
Blood samples will be collected to determine the AUC0-inf of Embibatinib administered with or without an acid-reducing agent.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib in Plasma Administered With or Without an Acid-Reducing Agent
Blood samples will be collected to determine the Cmax of Embibatinib administered with or without an acid-reducing agent.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Midazolam in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-Last of Midazolam administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Midazolam in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-inf of Midazolam administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Midazolam in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the Cmax of Midazolam administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Montelukast in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-Last of Montelukast administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Montelukast in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-inf of Montelukast administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Montelukast in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the Cmax of Montelukast administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Omeprazole in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-Last of Omeprazole administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Omeprazole in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-inf of Omeprazole administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Omeprazole in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the Cmax of Omeprazole administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Digoxin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-Last of Digoxin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Digoxin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-inf of Digoxin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Digoxin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the Cmax of Digoxin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Pravastatin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-Last of Pravastatin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Pravastatin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-inf of Pravastatin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Pravastatin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the Cmax of Pravastatin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Warfarin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-Last of Warfarin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Warfarin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-inf of Warfarin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Warfarin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the Cmax of Warfarin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Rosuvastatin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-Last of Rosuvastatin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Rosuvastatin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the AUC0-inf of Rosuvastatin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Rosuvastatin in Plasma Administered With or Without Embibatinib
Blood samples will be collected to determine the Cmax of Rosuvastatin administered with or without Embibatinib.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Embibatinib in Plasma Administered With or Without Itraconazole
Blood samples will be collected to determine the AUC0-Last of Embibatinib administered with or without itraconazole.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib in Plasma Administered With or Without Itraconazole
Blood samples will be collected to determine the AUC0-inf of Embibatinib administered with or without itraconazole.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib in Plasma Administered With or Without Itraconazole
Blood samples will be collected to determine the Cmax of Embibatinib administered with or without itraconazole.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Embibatinib in Plasma Administered With or Without Bosentan
Blood samples will be collected to determine the AUC0-Last of Embibatinib administered with or without Bosentan.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib in Plasma Administered With or Without Bosentan
Blood samples will be collected to determine the AUC0-inf of Embibatinib administered with or without Bosentan.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib in Plasma Administered With or Without Bosentan
Blood samples will be collected to determine the Cmax of Embibatinib administered with or without Bosentan.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Embibatinib in Plasma Administered With or Without Quinidine
Blood samples will be collected to determine the AUC0-Last of Embibatinib administered with or without Quinidine.
Measured: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib in Plasma Administered With or Without Quinidine
Blood samples will be collected to determine the AUC0-inf of Embibatinib administered with or without Quinidine.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib in Plasma Administered With or Without Quinidine
Blood samples will be collected to determine the Cmax of Embibatinib administered with or without Quinidine.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start21 Dec 2023
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838987
- Sponsor's protocol ID
- TERN701-1014
- Other IDs
- MK-4208-001, TERN701-1014
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Embibatinib, the Effects of Food, Acid-Reducing Agents, and Drug-Drug Interactions, and the Relative Bioavailability of New Tablet Formulations of Embibatinib.
- ClinicalTrials.gov ID
- NCT07838987
- Acronym / sponsor ID
- TERN701-1014
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to learn what happens to different doses and forms of Embibatinib in a healthy person's body over time. Researchers will compare what happens to different doses and forms of Embibatinib in a person's body over time when given with or without food, or with or without other medications.
The goal of the study is to learn:
- What happens to different doses of Embibatinib in a person's body over time when it is given with or without food, or with or without other medications.
- About the safety of Embibatinib and if people tolerate it
Detailed description
Per protocol, participants will be randomized in Cohort 7 to the sequence in which they receive two Embibatinib formulations. All other cohorts will be non-randomized.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 19
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Single Ascending Dose (SAD) Escalation of Embibatinib Dose Level 1 | Experimental | Drug: EmbibatinibParticipants receive a single oral dose of Embibatinib Dose Level 1 under fasted conditions on Day 1. |
| Cohort 2: SAD Escalation of Embibatinib Dose Level 2 | Experimental | Drug: EmbibatinibParticipants receive a single oral dose of Embibatinib Dose Level 2 under fasted conditions on Day 1. |
| Cohort 3: SAD Escalation of Embibatinib Dose Level 3 and Food Effect | Experimental | Drug: EmbibatinibOn Period 1 Day 1, participants receive a single oral dose of Embibatinib Dose Level 3 under fasted conditions. On Period 2 Day 1, participants receive Embibatinib Dose Level 3 after a high-fat meal. |
| Cohort 4: SAD Escalation of Embibatinib Dose Level 4 | Experimental | Drug: EmbibatinibParticipants receive a single oral dose of Embibatinib Dose Level 4 under fasted conditions on Day 1. |
| Cohort 5: SAD Escalation of Embibatinib Dose Level 5 | Experimental | Drug: EmbibatinibParticipants receive a single oral dose of Embibatinib Dose Level 5 under fasted conditions on Day 1. |
| Cohort 6: SAD Escalation of Embibatinib Dose Level 7 | Experimental | Drug: EmbibatinibParticipants receive a single oral dose of Embibatinib Dose Level 7 under fasted conditions on Day 1. |
| Cohort 7: Embibatinib Formulations with Rabeprazole 20 mg | Experimental | Drug: Embibatinib, Drug: RabeprazoleParticipants in Cohort 7 are randomized to receive Embibatinib Formulation 1 or Formulation 2 at Dose Level 5 on Day 1. On Day 7, participants receive Embibatinib Formulation 2 or Formulation 1 at Dose Level 5. Participants also receive Rabeprazole 20 mg once daily on Days 10-13. On Day 14, participants will co-administer a single oral dose of Rabeprazole 20 mg with Embibatinib Formulation 1 Dose Level 5 at the same time. All participants receive treatment under fasted conditions. |
| Cohort 8: Embibatinib + Probe Substrate Cocktail-1 | Experimental | Drug: Embibatinib, Drug: Midazolam, Drug: Digoxin, Drug: Pravastatin, Drug: Montelukast, Drug: OmeprazolePer protocol, the probe substrate cocktail-1 consists of midazolam 2 mg, digoxin 0.25 mg, pravastatin 40 mg, montelukast 10 mg, and omeprazole 40 mg. On Day 1, participants receive a single oral dose of the probe substrate cocktail-1 under fasted conditions. On Day 5, participants receive a single oral dose of Embibatinib Dose Level 4 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. On Day 9, participants receive a single oral dose of Embibatinib Dose Level 7 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. |
| Cohort 9: Embibatinib Dose Level 5 + Rabeprazole 20 mg | Experimental | Drug: Embibatinib, Drug: RabeprazoleParticipants receive a single oral dose of Embibatinib Dose Level 5 on Day 1 under fasted conditions. On Days 4-7 participants will receive Rabeprazole 20 mg once daily under fasted conditions. On Day 8, under fasted conditions, participants co-administer a single oral dose of Embibatinib Dose Level 5 with a single oral dose of Rabeprazole 20 mg taken at the same time under fasted conditions. |
| Cohort 10: SAD Escalation of Embibatinib Dose Level 8 | Experimental | Drug: EmbibatinibParticipants receive a single oral dose of Embibatinib Dose Level 8 under fasted conditions on Day 1. |
| Cohort 11: SAD Escalation of Embibatinib Dose Level 9 | Experimental | Drug: EmbibatinibParticipants receive a single oral dose of Embibatinib Dose Level 9 under fasted conditions on Day 1. |
| Cohort 12: Embibatinib Dose Level 3 + Itraconazole 200 mg | Experimental | Drug: Embibatinib, Drug: ItraconazoleParticipants receive a single oral dose of Embibatinib at Dose Level 3 under nonfasted conditions on Day 1. On Day 8, participants will receive Itraconazole 200 mg twice daily after a standardized breakfast and evening snack. On Days 9-11, participants will take a single oral dose of Itraconazole 200 mg after a standardized meal. On Day 12, participants will take a single dose of Itraconazole 200mg after a standardized meal followed by Embibatinib Dose Level 3 taken an hour later. Participants will continue taking a single oral dose of Itraconazole 200 mg once daily after a standardized meal on Days 13-15. |
| Cohort 13: Multiple Ascending Dose (MAD) Escalation of Embibatinib Dose Level 4 | Experimental | Drug: EmbibatinibParticipants receive an oral dose of Embibatinib Dose Level 4 once daily from Day 1 to Day 13 under fasted conditions. |
| Cohort 14: Embibatinib Dose Level 5 + Probe Substrate Cocktail-2 | Experimental | Drug: Embibatinib, Drug: Midazolam, Drug: Warfarin, Drug: RosuvastatinPer protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of Embibatinib Dose Level 5 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with Embibatinib Dose Level 5 taken at the same time under fasted conditions. On Days 17-21 participants receive Embibatinib Dose Level 5 as a single oral dose once daily under fasted conditions. |
| Cohort 15: Embibatinib Dose Level 8 + Probe Substrate Cocktail-2 | Experimental | Drug: Embibatinib, Drug: Midazolam, Drug: Warfarin, Drug: RosuvastatinPer protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of Embibatinib Dose Level 8 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with Embibatinib Dose Level 8 taken at the same time under fasted conditions. On Days 17-21 participants receive Embibatinib Dose Level 8 as a single oral dose once daily under fasted conditions. |
| Cohort 16: Food Effect on Embibatinib Dose Level 8 Formulations with Rabeprazole 20 mg | Experimental | Drug: Embibatinib, Drug: RabeprazoleOn Period 1 Day 1, participants receive a single oral dose of Embibatinib Formulation 3 Dose Level 8 (DL8). On Period 1 Day 7, participants receive a single oral dose of Embibatinib Formulation 4 DL8. On Period 1 Day 13, participants receive a single oral dose of Embibatinib Formulation 5 DL8. On Period 1 Day 19, participants receive a single oral dose of Embibatinib Formulation 6 DL8. All Period 1 treatments are administered under fasted conditions. Per protocol, following Period 1, one formulation is selected for Period 2. On Period 2 Day 1, participants receive a single oral dose of the selected Embibatinib formulation DL8 after a high-fat meal. On Period 2 Days 7-10, participants receive rabeprazole 20 mg once daily under fasted conditions. On Period 2 Day 11, participants receive the selected formulation of Embibatinib DL8 as a single oral dose, co-administered with the single oral dose of Rabeprazole 20 mg taken at the same time under fasted conditions. |
| Cohort 17: Food Effect on Embibatinib Dose Level 8 Selected Formulation with Rabeprazole 20 mg | Experimental | Drug: Embibatinib, Drug: RabeprazolePer protocol, a formulation from Cohort 16 Period 1, different from the formulation selected for Cohort 16 Period 2, may be selected to evaluate the effects of food and rabeprazole 20 mg. On Day 1, participants receive a single oral dose of the selected formulation of Embibatinib Dose Level 8 under fasted conditions. On Day 7, participants receive a single oral dose of the selected formulation of Embibatinib Dose Level 8 after a high-fat meal. On Days 13-16, participants receive a single oral dose of rabeprazole 20 mg once daily. On Day 17, participants receive a single oral dose of the selected formulation of Embibatinib Dose Level 8 co-administered with a single oral dose of rabeprazole 20 mg taken at the same time under fasted conditions. |
| Cohort 18: Embibatinib Dose Level 8 + Bosentan 125 mg | Experimental | Drug: Embibatinib, Drug: BosentanOn Day 1, participants receive a single oral dose of Embibatinib Dose Level 8 under fasted conditions. Beginning on Day 8, participants receive an oral dose of Bosentan 125 mg twice daily. On Day 15, participants receive Embibatinib Dose Level 8 as a single oral dose co-administered with the morning dose of Bosentan 125 mg taken at the same time under fasted conditions; participants then receive the second daily dose of Bosentan 125 mg in the evening. Participants continue taking Bosentan 125 mg twice daily on Days 16-18. |
| Cohort 19: Embibatinib Dose Level 6 + Quinidine 300 mg | Experimental | Drug: Embibatinib, Drug: QuinidineParticipants receive a single oral dose of Embibatinib Dose Level 6 on Day 1 under fasted conditions. Beginning on Day 6, participants receive an oral dose of Quinidine 300 mg three times daily. On Day 8, participants receive Embibatinib Dose Level 6 as a single oral dose co-administered with the morning final dose of Quinidine 300 mg taken at the same time under fasted conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has body weight ≥48 kg (105.6 lbs) and body mass index within the range of 18.5 to 32 kg/m^2 (inclusive)
- Is in good health
Key exclusion criteria (5 listed)
- Has history or clinical manifestation of any metabolic, allergic, autoimmune, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, ocular, respiratory, endocrine, or psychiatric disorder, or any condition that would affect drug absorption, distribution, metabolism, or excretion (eg, stomach or intestinal surgery, or gallbladder removal/cholecystectomy). Uncomplicated appendectomy and hernia repair will be allowed.
- Has history of QT prolongation syndrome, unexplained syncope, family history of sudden death, atrial fibrillation, malignant tumor, mental disorder, or any major disease
- Has positive screening test for Hepatitis B surface antigen, anti-Hepatitis C virus antibodies, or anti-Human immunodeficiency virus (HIV) 1 and 2 antibodies
- Has any known history of bleeding, or prothrombin time (Embibatinib + Probe Substrate Cocktail-2 arm only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmbibatinibAlso: MK-4208, HS-10382Oral Tablet | Drug | Cohort 10: SAD Escalation of Embibatinib Dose Level 8, Cohort 11: SAD Escalation of Embibatinib Dose Level 9, Cohort 12: Embibatinib Dose Level 3 + Itraconazole 200 mg, Cohort 13: Multiple Ascending Dose (MAD) Escalation of Embibatinib Dose Level 4, Cohort 14: Embibatinib Dose Level 5 + Probe Substrate Cocktail-2, Cohort 15: Embibatinib Dose Level 8 + Probe Substrate Cocktail-2, Cohort 16: Food Effect on Embibatinib Dose Level 8 Formulations with Rabeprazole 20 mg, Cohort 17: Food Effect on Embibatinib Dose Level 8 Selected Formulation with Rabeprazole 20 mg, Cohort 18: Embibatinib Dose Level 8 + Bosentan 125 mg, Cohort 19: Embibatinib Dose Level 6 + Quinidine 300 mg, Cohort 1: Single Ascending Dose (SAD) Escalation of Embibatinib Dose Level 1, Cohort 2: SAD Escalation of Embibatinib Dose Level 2, Cohort 3: SAD Escalation of Embibatinib Dose Level 3 and Food Effect, Cohort 4: SAD Escalation of Embibatinib Dose Level 4, Cohort 5: SAD Escalation of Embibatinib Dose Level 5, Cohort 6: SAD Escalation of Embibatinib Dose Level 7, Cohort 7: Embibatinib Formulations with Rabeprazole 20 mg, Cohort 8: Embibatinib + Probe Substrate Cocktail-1, Cohort 9: Embibatinib Dose Level 5 + Rabeprazole 20 mg |
| RabeprazoleThe United States commercially marketed 20 mg oral tablet formulation is being used in this trial. | Drug | Cohort 16: Food Effect on Embibatinib Dose Level 8 Formulations with Rabeprazole 20 mg, Cohort 17: Food Effect on Embibatinib Dose Level 8 Selected Formulation with Rabeprazole 20 mg, Cohort 7: Embibatinib Formulations with Rabeprazole 20 mg, Cohort 9: Embibatinib Dose Level 5 + Rabeprazole 20 mg |
| Midazolam2 mg oral syrup formulation administered as part of the probe substrate cocktail-1 and probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial. | Drug | Cohort 14: Embibatinib Dose Level 5 + Probe Substrate Cocktail-2, Cohort 15: Embibatinib Dose Level 8 + Probe Substrate Cocktail-2, Cohort 8: Embibatinib + Probe Substrate Cocktail-1 |
| Digoxin0.25 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial. | Drug | Cohort 8: Embibatinib + Probe Substrate Cocktail-1 |
| Pravastatin40 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial. | Drug | Cohort 8: Embibatinib + Probe Substrate Cocktail-1 |
| Montelukast10 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial. | Drug | Cohort 8: Embibatinib + Probe Substrate Cocktail-1 |
| Omeprazole40 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial. | Drug | Cohort 8: Embibatinib + Probe Substrate Cocktail-1 |
| ItraconazoleThe United States commercially marketed 200 mg oral capsule formulation is being used in this trial. | Drug | Cohort 12: Embibatinib Dose Level 3 + Itraconazole 200 mg |
| Warfarin5 mg oral tablet formulation administered as part of the probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial. | Drug | Cohort 14: Embibatinib Dose Level 5 + Probe Substrate Cocktail-2, Cohort 15: Embibatinib Dose Level 8 + Probe Substrate Cocktail-2 |
| Rosuvastatin10 mg oral tablet formulation administered as part of the probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial. | Drug | Cohort 14: Embibatinib Dose Level 5 + Probe Substrate Cocktail-2, Cohort 15: Embibatinib Dose Level 8 + Probe Substrate Cocktail-2 |
| BosentanThe Europe commercially marketed 125 mg oral tablet formulation is being used in this trial. | Drug | Cohort 18: Embibatinib Dose Level 8 + Bosentan 125 mg |
| QuinidineThe United States commercially marketed 300 mg oral tablet formulation is being used in this trial. | Drug | Cohort 19: Embibatinib Dose Level 6 + Quinidine 300 mg |
Primary outcome
Number of Participants Who Experience a Treatment Emergent Adverse Event (AE)
Time frame: Up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience a treatment emergent AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Number of Participants with Clinically Significant Abnormalities in Systolic Blood Pressure
Time frame: up to approximately 102 days
Blood pressure will be measured after the participant has been at rest in a supine position for at least 10 minutes. Blood pressure and pulse measurements will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available. Blood pressure measurements will be carried out before blood sample collections or at least 30 minutes after any blood draws.
Number of Participants with Clinically Significant Abnormalities in Diastolic Blood Pressure
Time frame: up to approximately 102 days
Blood pressure will be measured after the participant has been at rest in a supine position for at least 10 minutes. Blood pressure and pulse measurements will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available. Blood pressure measurements will be carried out before blood sample collections or at least 30 minutes after any blood draws.
Number of Participants with Abnormal Clinical Hematology Test Results Reported as Adverse Events
Time frame: up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal hematology-related AEs will be reported.
Number of Participants with Abnormal Clinical Chemistry Test Results Reported as Adverse Events
Time frame: up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal chemistry-related AEs will be reported.
Number of Participants with Abnormal Urinalysis Results Reported as Adverse Events
Time frame: up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal urinalysis-related AEs will be reported.
Number of Participants with Clinically Significant Abnormalities in 12-Lead (ECG) Findings
Time frame: up to approximately 102 days
During the 12-lead ECG collection participants will be instructed to lie supine for at least 10 minutes prior to ECG collection. During the collection, participants should be in a quiet setting, without distractions, and should refrain from talking or moving their arms or legs. All ECG acquisitions will be carried out before any blood sample collections or at least 30 minutes after any blood draws.
Area Under the Concentration versus Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of Embibatinib in Plasma
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of Embibatinib.
Area Under the Concentration versus Time Curve Extrapolated to Infinite Time (AUC0-Inf) of Embibatinib in Plasma
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of Embibatinib.
Area Under the Concentration versus Time Curve Over the Dosing Interval (AUCtau) of Embibatinib in Plasma
Time frame: Pre-dose and at designated time points up to 24 hours post dose
Blood samples will be collected to determine the AUCtau of Embibatinib.
Maximum Observed Concentration of Drug (Cmax) of Embibatinib in Plasma
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of Embibatinib.
Apparent Terminal Elimination Half-Life (t1/2) of Embibatinib in Plasma
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the t1/2 of Embibatinib.
Time of Maximum Observed Concentration of Drug (Tmax) of Embibatinib in Plasma
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Tmax of Embibatinib.
40 secondary outcomes
AUC0-last of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Tmax of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Embibatinib Formulations in Plasma
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib Formulations in Plasma
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib Formulations in Plasma
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Embibatinib in Plasma Administered With or Without an Acid-Reducing Agent
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib in Plasma Administered With or Without an Acid-Reducing Agent
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib in Plasma Administered With or Without an Acid-Reducing Agent
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Midazolam in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Midazolam in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Midazolam in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Montelukast in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Montelukast in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Montelukast in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Omeprazole in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Omeprazole in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Omeprazole in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Digoxin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Digoxin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Digoxin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Pravastatin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Pravastatin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Pravastatin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Warfarin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Warfarin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Warfarin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Rosuvastatin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Rosuvastatin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Rosuvastatin in Plasma Administered With or Without Embibatinib
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Embibatinib in Plasma Administered With or Without Itraconazole
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib in Plasma Administered With or Without Itraconazole
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib in Plasma Administered With or Without Itraconazole
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Embibatinib in Plasma Administered With or Without Bosentan
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib in Plasma Administered With or Without Bosentan
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib in Plasma Administered With or Without Bosentan
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-last of Embibatinib in Plasma Administered With or Without Quinidine
Time frame: Pre-dose and at designated time points up to 96 hours post dose
AUC0-Inf of Embibatinib in Plasma Administered With or Without Quinidine
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Cmax of Embibatinib in Plasma Administered With or Without Quinidine
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Embibatinib, Rabeprazole and Midazolam in people with Healthy, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience a Treatment Emergent Adverse Event (AE) (time frame: Up to approximately 102 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.