HealthyPhase 1NCT06942741
A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011)
A Phase 1 study testing Calderasib OCT and Calderasib FCT in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
This study has 2 parts. Researchers want to learn what happens to calderasib in a healthy person's body over time in both parts. The goals of the study are: In Part 1, to compare what happens to calderasib in a person's blood when it is taken as 2 different types of oral tablets In Part 2, to learn what happens to… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Calderasib OCT and Calderasib FCT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to 4 Aug 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has a body mass index ≥18.0 and ≤32.0 kg/m^2
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has a history or presence of a clinically significant medical or psychiatric condition or disease
- Has a history of cancer (malignancy)
- Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part Study to Determine Bioequivalence Between the MK-1084 Film-Coated Tablet and Oral-Compressed Tablet and the Effect of Food on the Single-Dose Pharmacokinetics of the MK-1084 Film-Coated Tablet in Healthy Adult Participants
This study has 2 parts. Researchers want to learn what happens to calderasib in a healthy person's body over time in both parts. The goals of the study are:
- In Part 1, to compare what happens to calderasib in a person's blood when it is taken as 2 different types of oral tablets
- In Part 2, to learn what happens to calderasib in a person's blood when it is taken on an empty stomach or after a meal
- Conditions
- Healthy
- Being tested
- Calderasib OCT, Calderasib FCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calderasib OCTDrug
Also called MK-1084 OCT
Oral tablet
Calderasib FCTDrug
Also called MK-1084 FCT
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Calderasib Treatment A | Experimental | Participants will be administered low dose calderasib as an oral-compressed tablet (OCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast) Receives: Drug: Calderasib OCT |
| Part 1 Calderasib Treatment B | Experimental | Participants will be administered low dose calderasib as a film-coated tablet (FCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast) Receives: Drug: Calderasib FCT |
| Part 2 Calderasib Treatment C | Experimental | Participants will be administered higher dose calderasib as a FCT on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast) Receives: Drug: Calderasib FCT |
| Part 2 Calderasib Treatment D | Experimental | Participants will be administered higher dose calderasib as a FCT on Day 1 under fed conditions (after a high-fat meal) Receives: Drug: Calderasib FCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Calderasib
Blood samples will be collected to determine the AUC0-last of calderasib.
Measured: At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Calderasib
Blood samples will be collected to determine the AUC0-inf of calderasib.
Measured: At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib
Blood samples will be collected to determine the AUC0-24 of calderasib.
Measured: At designated timepoints (up to 24 hours postdose)
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Calderasib
Blood samples will be collected to determine the Cmax of calderasib.
Measured: At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Plasma Concentration of Calderasib at 24 Hours Postdose (C24)
Blood samples will be collected to determine the C24 of calderasib.
Measured: At designated timepoints (up to 24 hours postdose)
Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of Calderasib
Blood samples will be collected to determine the Tmax of calderasib.
Measured: At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Apparent Terminal Half-life (t1/2) of Calderasib
Blood samples will be collected to determine the t1/2 of calderasib.
Measured: At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Apparent Clearance (CL/F) of Calderasib
Blood samples will be collected to determine the CL/F of calderasib.
Measured: At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
Blood samples will be collected to determine the Vz/F of calderasib.
Measured: At designated timepoints (up to approximately 2 days postdose)
Part 2: Plasma Lag Time (tlag) of Calderasib
Blood samples will be collected to determine the tlag of calderasib.
Measured: At designated timepoints (up to approximately 2 days postdose)
Secondary outcomes (2)
Parts 1 and 2: Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported
Measured: Up to approximately 7 weeks
Parts 1 and 2: 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 treatment, whether or not considered related to the study treatment. The number of participants who discontinue from the study treatment due to an AE will be reported.
Measured: Up to approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start13 May 2025
- Primary completion22 Jun 2025
- Study completion4 Aug 2025
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.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- 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
- NCT06942741
- Sponsor's protocol ID
- 1084-011
- Other IDs
- MK-1084-011
- Status last verified
- Feb 2026
- First submitted
- 17 Apr 2025
- Last updated
- 11 Feb 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Study to Determine Bioequivalence Between the MK-1084 Film-Coated Tablet and Oral-Compressed Tablet and the Effect of Food on the Single-Dose Pharmacokinetics of the MK-1084 Film-Coated Tablet in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06942741
- Acronym / sponsor ID
- 1084-011
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 13 May 2025 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 24 Apr 2025 (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.
This study has 2 parts. Researchers want to learn what happens to calderasib in a healthy person's body over time in both parts. The goals of the study are:
- In Part 1, to compare what happens to calderasib in a person's blood when it is taken as 2 different types of oral tablets
- In Part 2, to learn what happens to calderasib in a person's blood when it is taken on an empty stomach or after a meal
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 Calderasib Treatment A | Experimental | Drug: Calderasib OCTParticipants will be administered low dose calderasib as an oral-compressed tablet (OCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast) |
| Part 1 Calderasib Treatment B | Experimental | Drug: Calderasib FCTParticipants will be administered low dose calderasib as a film-coated tablet (FCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast) |
| Part 2 Calderasib Treatment C | Experimental | Drug: Calderasib FCTParticipants will be administered higher dose calderasib as a FCT on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast) |
| Part 2 Calderasib Treatment D | Experimental | Drug: Calderasib FCTParticipants will be administered higher dose calderasib as a FCT on Day 1 under fed conditions (after a high-fat meal) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has a body mass index ≥18.0 and ≤32.0 kg/m^2
Key exclusion criteria (4 listed)
- Has a history or presence of a clinically significant medical or psychiatric condition or disease
- Has a history of cancer (malignancy)
- Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus
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 |
|---|---|---|
| Calderasib OCTAlso: MK-1084 OCTOral tablet | Drug | Part 1 Calderasib Treatment A |
| Calderasib FCTAlso: MK-1084 FCTOral tablet | Drug | Part 1 Calderasib Treatment B, Part 2 Calderasib Treatment C, Part 2 Calderasib Treatment D |
Primary outcome
Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Calderasib
Time frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the AUC0-last of calderasib.
Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Calderasib
Time frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib
Time frame: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24 of calderasib.
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Calderasib
Time frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the Cmax of calderasib.
Parts 1 and 2: Plasma Concentration of Calderasib at 24 Hours Postdose (C24)
Time frame: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the C24 of calderasib.
Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of Calderasib
Time frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the Tmax of calderasib.
Parts 1 and 2: Apparent Terminal Half-life (t1/2) of Calderasib
Time frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the t1/2 of calderasib.
Parts 1 and 2: Apparent Clearance (CL/F) of Calderasib
Time frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the CL/F of calderasib.
Parts 1 and 2: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
Time frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the Vz/F of calderasib.
Part 2: Plasma Lag Time (tlag) of Calderasib
Time frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the tlag of calderasib.
2 secondary outcomes
Parts 1 and 2: Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 7 weeks
Parts 1 and 2: Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 1 week
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 11 Feb 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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 Calderasib OCT and Calderasib FCT in people with Healthy, run by Merck Sharp & Dohme LLC 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 2 inclusion and 4 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 11 Feb 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?
Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Calderasib (time frame: At designated timepoints (up to approximately 2 days postdose)). The study lists 10 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 11 Feb 2026.