Healthy VolunteerPhase 1NCT07395024
A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
A Phase 1 study testing Setidegrasib, Fluconazole and Carbamazepine in people with Healthy Volunteer, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with solid tumors have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Setidegrasib, Fluconazole and Carbamazepine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2026to 2 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participant is healthy and has no clinically significant medical condition based on the physical examination, electrocardiograms (ECGs) and protocol-defined clinical laboratory tests at screening or on day -1.
- Female participant is not pregnant and is not a woman of childbearing potential (WOCBP)
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (approximately 28 days after final study intervention administration).
- Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 3 months after final study intervention administration.
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 3 months after final study intervention administration.
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 3 months after final study intervention administration.
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- Male participant must not donate sperm during the treatment period and for 3 months after final study intervention administration.
- Participant agrees not to participate in another interventional study while participating in the present study.
- Participant has a Body Mass Index (BMI) range of 18.0 to 32.0 kg/m^2, inclusive, and weighs at least 50 kg at screening.
Who cannot join
- Participant is positive for Human Leukocyte Antigen (HLA) -B15:02 or HLA-A31:01, for Group 2 only.
- Participant has been pregnant within 6 months prior to screening.
- Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease.
- Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that is considered cured with minimal risk of recurrence).
- Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives (approximately 28 days) after the last dose of study drug administration or end-of-study visit (ESV), whichever is longer.
- Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day -1.
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- Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) DSM-5 criteria within 2 years before screening.
- Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.
- Participant has used any prescribed or nonprescribed drugs (including vitamins, and natural and herbal remedies, e.g., St. John's wort) in the 28 days prior to day -1, except for occasional use of acetaminophen (up to 2 g/day), topical dermatological products (including corticosteroid products) and hormone replacement therapy (HRT).
- Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 28 days prior to day -1.
- Participant has received a coronavirus disease 2019 (COVID-19) vaccine within the 14 days prior to day -1 or will have a COVID-19 vaccine dose before the ESV.
- Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Participant has any liver test result alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBL )) ≥ 1.5 ×upper limit of normal (ULN ) on day -1.
- Participant has a creatinine level outside normal limits on day -1.
- Participant has any of the following conditions on day -1: a mean pulse < 45 or > 90 bpm, mean systolic blood pressure (SBP ) > 140 mmHg, or mean diastolic blood pressure (DBP) > 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse measured automatically). If the mean blood pressure exceeds the limits above, 1 additional triplicate measurement may be taken.
- Participant has a mean corrected QT interval using Fridericia's formula (QTcF ) of > 450 msec on day -1.
- Participant tests positive for alcohol at screening or on day -1.
- Participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) at screening or on day -1.
- Participant tests positive for cannabinoids on day -1.
- Participant has a positive serology test for hepatitis A virus (HAV) antibodies immunoglobulin M (IgM), hepatitis B (HBc) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or antibodies to human immunodeficiency virus (HIV ) type 1 and/or type 2 at screening.
- Participant has a positive rapid COVID-19 antigen test on day -1.
- Participant has any condition that makes the participant unsuitable for study participation.
- Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.
- Participant has a history of smoking > 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1 or the participant tests positive for cotinine at screening or day -1.
- Participant has a history of consuming > 10 units of alcoholic beverages per week within 3 months prior to screening (Note: 1 unit = 12 ounces of beer, 5 ounces of wine, 1.5 ounces of spirits/hard liquor).
- Participant has used any drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine and/or opiates) within 3 months prior to day -1.
- Participant has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days prior to day -1.
- Participant has had previous exposure to ASP3082.
- Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Crossover Design Study to Assess the Effect of CYP3A Moderate and Strong Inhibitors (Fluconazole and Itraconazole) and Strong Inducer (Carbamazepine) on the Single-dose Pharmacokinetics of ASP3082 in Healthy Adults
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with solid tumors have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation.
ASP3082 is thought to replace some of the abnormal proteins made from the faulty KRAS gene. If other medicines are given at the same time as ASP3082, they may affect how the body processes ASP3082.
Read more
In this study, fluconazole, itraconazole and carbamazepine are given with ASP3082 in healthy adults. The main aims are to check if fluconazole, itraconazole and carbamazepine affect how the body processes ASP3082. These medicines may affect how the body processes ASP3082 when they are taken at the same time.
This study will have 3 groups of adults. One group will be given fluconazole and ASP3082, the second group will be given carbamazepine and ASP3082, and the third group will be given itraconazole and ASP3082. ASP3082 will be given to people slowly through a tube into the vein (infusion). Fluconazole and carbamazepine will be given as a tablet and itraconazole will be given as a liquid by mouth. People will be given study treatments for about 1 month. They will then return to the clinic about 1 week after they finish study treatment for a final safety check.
- Conditions
- Healthy Volunteer
- Being tested
- Setidegrasib, Fluconazole, Carbamazepine, Itraconazole
- Keywords
- ASP3082, Pharmacokinetics, Setidegrasib, Healthy Volunteers, Fluconazole, Itraconazole, Carbamazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SetidegrasibDrug
Also called ASP3082
Intravenous (IV) infusion
FluconazoleDrug
Oral
CarbamazepineDrug
Oral
ItraconazoleDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ASP3082 + Fluconazole | Experimental | Participants receive ASP3082 on Days 1 and 15 and fluconazole on Days 8 to 28. Receives: Drug: Setidegrasib; Drug: Fluconazole |
| Group 2: ASP3082 + Carbamazepine | Experimental | Participants receive ASP3082 on Days 1 and 22 and carbamazepine on Days 8 to 28. Receives: Drug: Setidegrasib; Drug: Carbamazepine |
| Group 3: ASP3082 + Itraconazole | Experimental | Participants receive ASP3082 on Days 1 and 15 and itraconazole on Days 8 to 28. Receives: Drug: Setidegrasib; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of ASP3082 in plasma: Maximum Concentration (Cmax) in ASP3082
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: area under the concentration-time curve from time zero to the time of the last measurable concentration (AUClast) in ASP3082
AUClast will be recorded from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: area under the concentration-time curve extrapolated to infinity (AUCinf) in ASP3082
AUCinf will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: Cmax in ASP3082+ Fluconazole (FLZ)
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: AUClast in ASP3082+FLZ
AUClast will be recorded from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: AUCinf in ASP3082+FLZ
AUCinf will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
Ratio of Cmax of ASP3082 and ASP3082+FLZ
Ratios of Cmax will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
Ratio of AUClast of ASP3082 and ASP3082+FLZ
Ratios of AUClast will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
Ratio of AUCinf of ASP3082 and ASP3082+FLZ
Ratios of AUCinf will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: Cmax in ASP3082+ Itraconazole (ITZ)
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: AUClast in ASP3082+ITZ
AUClast will be recorded from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: AUCinf in ASP3082+ITZ
AUCinf will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
Ratio of Cmax of ASP3082 and ASP3082+ITZ
Ratios of Cmax will be recorded from the PK plasma samples collected.
Measured: Up to 29 days
Ratio of AUClast for ASP3082 and ASP3082+ITZ
Ratios of AUClast will be recorded from the PK plasma samples collected.
Measured: Up to 29 days
Ratio of AUCinf for ASP3082 and ASP3082+ITZ
Ratios of AUCinf will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: Cmax in ASP3082+ Carbamazepine (CAR)
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: AUClast in ASP3082+CAR
AUClast will be recorded from the PK plasma samples collected.
Measured: Up to 29 days
PK of ASP3082 in plasma: AUCinf in ASP3082+CAR
AUCinf will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
Ratio of Cmax of ASP3082 and ASP3082+CAR
Ratios of Cmax will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
Ratio of AUClast for ASP3082 and ASP3082+CAR
Ratios of AUClast will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
Ratio of AUCinf for ASP3082 and ASP3082+CAR
Ratios of AUCinf will be calculated from the PK plasma samples collected.
Measured: Up to 29 days
Secondary outcomes (7)
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Measured: Up to 36 days
Number of Participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 36 days
Number of Participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 36 days
Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Measured: Up to 36 days
PK of FLZ in plasma: trough concentration (Ctrough)
Ctrough of FLZ will be recorded from the PK samples collected.
Measured: Up to 25 days
PK of CAR in plasma Ctrough
Ctrough of CAR will be recorded from the PK samples collected.
Measured: Up to 28 days
PK of ITZ in plasma Ctrough
Ctrough of ITZ will be recorded from the PK samples collected.
Measured: Up to 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start3 Feb 2026
- Primary completion2 May 2027 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395024
- Sponsor's protocol ID
- 3082-CL-0102
- Status last verified
- Aug 2026
- First submitted
- 28 Jan 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Crossover Design Study to Assess the Effect of CYP3A Moderate and Strong Inhibitors (Fluconazole and Itraconazole) and Strong Inducer (Carbamazepine) on the Single-dose Pharmacokinetics of ASP3082 in Healthy Adults
- ClinicalTrials.gov ID
- NCT07395024
- Acronym / sponsor ID
- 3082-CL-0102
- Conditions
- Healthy Volunteer
- Keywords
- ASP3082, Pharmacokinetics, Setidegrasib, Healthy Volunteers, Fluconazole, Itraconazole, Carbamazepine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 9 Feb 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.
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with solid tumors have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation.
ASP3082 is thought to replace some of the abnormal proteins made from the faulty KRAS gene. If other medicines are given at the same time as ASP3082, they may affect how the body processes ASP3082.
In this study, fluconazole, itraconazole and carbamazepine are given with ASP3082 in healthy adults. The main aims are to check if fluconazole, itraconazole and carbamazepine affect how the body processes ASP3082. These medicines may affect how the body processes ASP3082 when they are taken at the same time.
This study will have 3 groups of adults. One group will be given fluconazole and ASP3082, the second group will be given carbamazepine and ASP3082, and the third group will be given itraconazole and ASP3082. ASP3082 will be given to people slowly through a tube into the vein (infusion). Fluconazole and carbamazepine will be given as a tablet and itraconazole will be given as a liquid by mouth. People will be given study treatments for about 1 month. They will then return to the clinic about 1 week after they finish study treatment for a final safety check.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: ASP3082 + Fluconazole | Experimental | Drug: Setidegrasib, Drug: FluconazoleParticipants receive ASP3082 on Days 1 and 15 and fluconazole on Days 8 to 28. |
| Group 2: ASP3082 + Carbamazepine | Experimental | Drug: Setidegrasib, Drug: CarbamazepineParticipants receive ASP3082 on Days 1 and 22 and carbamazepine on Days 8 to 28. |
| Group 3: ASP3082 + Itraconazole | Experimental | Drug: Setidegrasib, Drug: ItraconazoleParticipants receive ASP3082 on Days 1 and 15 and itraconazole on Days 8 to 28. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant is healthy and has no clinically significant medical condition based on the physical examination, electrocardiograms (ECGs) and protocol-defined clinical laboratory tests at screening or on day -1.
- Female participant is not pregnant and is not a woman of childbearing potential (WOCBP)
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (approximately 28 days after final study intervention administration).
- Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 3 months after final study intervention administration.
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 3 months after final study intervention administration.
Key exclusion criteria (29 listed)
- Participant is positive for Human Leukocyte Antigen (HLA) -B15:02 or HLA-A31:01, for Group 2 only.
- Participant has been pregnant within 6 months prior to screening.
- Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease.
- Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that is considered cured with minimal risk of recurrence).
- Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives (approximately 28 days) after the last dose of study drug administration or end-of-study visit (ESV), whichever is longer.
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 |
|---|---|---|
| SetidegrasibAlso: ASP3082Intravenous (IV) infusion | Drug | Group 1: ASP3082 + Fluconazole, Group 2: ASP3082 + Carbamazepine, Group 3: ASP3082 + Itraconazole |
| FluconazoleOral | Drug | Group 1: ASP3082 + Fluconazole |
| CarbamazepineOral | Drug | Group 2: ASP3082 + Carbamazepine |
| ItraconazoleOral | Drug | Group 3: ASP3082 + Itraconazole |
Primary outcome
Pharmacokinetics (PK) of ASP3082 in plasma: Maximum Concentration (Cmax) in ASP3082
Time frame: Up to 29 days
Cmax will be recorded from the PK plasma samples collected.
PK of ASP3082 in plasma: area under the concentration-time curve from time zero to the time of the last measurable concentration (AUClast) in ASP3082
Time frame: Up to 29 days
AUClast will be recorded from the PK plasma samples collected.
PK of ASP3082 in plasma: area under the concentration-time curve extrapolated to infinity (AUCinf) in ASP3082
Time frame: Up to 29 days
AUCinf will be calculated from the PK plasma samples collected.
PK of ASP3082 in plasma: Cmax in ASP3082+ Fluconazole (FLZ)
Time frame: Up to 29 days
Cmax will be recorded from the PK plasma samples collected.
PK of ASP3082 in plasma: AUClast in ASP3082+FLZ
Time frame: Up to 29 days
AUClast will be recorded from the PK plasma samples collected.
PK of ASP3082 in plasma: AUCinf in ASP3082+FLZ
Time frame: Up to 29 days
AUCinf will be calculated from the PK plasma samples collected.
Ratio of Cmax of ASP3082 and ASP3082+FLZ
Time frame: Up to 29 days
Ratios of Cmax will be calculated from the PK plasma samples collected.
Ratio of AUClast of ASP3082 and ASP3082+FLZ
Time frame: Up to 29 days
Ratios of AUClast will be calculated from the PK plasma samples collected.
Ratio of AUCinf of ASP3082 and ASP3082+FLZ
Time frame: Up to 29 days
Ratios of AUCinf will be calculated from the PK plasma samples collected.
PK of ASP3082 in plasma: Cmax in ASP3082+ Itraconazole (ITZ)
Time frame: Up to 29 days
Cmax will be recorded from the PK plasma samples collected.
PK of ASP3082 in plasma: AUClast in ASP3082+ITZ
Time frame: Up to 29 days
AUClast will be recorded from the PK plasma samples collected.
PK of ASP3082 in plasma: AUCinf in ASP3082+ITZ
Time frame: Up to 29 days
AUCinf will be calculated from the PK plasma samples collected.
Ratio of Cmax of ASP3082 and ASP3082+ITZ
Time frame: Up to 29 days
Ratios of Cmax will be recorded from the PK plasma samples collected.
Ratio of AUClast for ASP3082 and ASP3082+ITZ
Time frame: Up to 29 days
Ratios of AUClast will be recorded from the PK plasma samples collected.
Ratio of AUCinf for ASP3082 and ASP3082+ITZ
Time frame: Up to 29 days
Ratios of AUCinf will be calculated from the PK plasma samples collected.
PK of ASP3082 in plasma: Cmax in ASP3082+ Carbamazepine (CAR)
Time frame: Up to 29 days
Cmax will be recorded from the PK plasma samples collected.
PK of ASP3082 in plasma: AUClast in ASP3082+CAR
Time frame: Up to 29 days
AUClast will be recorded from the PK plasma samples collected.
PK of ASP3082 in plasma: AUCinf in ASP3082+CAR
Time frame: Up to 29 days
AUCinf will be calculated from the PK plasma samples collected.
Ratio of Cmax of ASP3082 and ASP3082+CAR
Time frame: Up to 29 days
Ratios of Cmax will be calculated from the PK plasma samples collected.
Ratio of AUClast for ASP3082 and ASP3082+CAR
Time frame: Up to 29 days
Ratios of AUClast will be calculated from the PK plasma samples collected.
Ratio of AUCinf for ASP3082 and ASP3082+CAR
Time frame: Up to 29 days
Ratios of AUCinf will be calculated from the PK plasma samples collected.
7 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: Up to 36 days
Number of Participants with laboratory value abnormalities and/or AEs
Time frame: Up to 36 days
Number of Participants with vital sign abnormalities and/or AEs
Time frame: Up to 36 days
Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to 36 days
PK of FLZ in plasma: trough concentration (Ctrough)
Time frame: Up to 25 days
PK of CAR in plasma Ctrough
Time frame: Up to 28 days
PK of ITZ in plasma Ctrough
Time frame: Up to 25 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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
Astellas Pharma Inc
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 Setidegrasib, Fluconazole and Carbamazepine in people with Healthy Volunteer, run by Astellas Pharma Global Development, Inc. 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 9 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Pharmacokinetics (PK) of ASP3082 in plasma: Maximum Concentration (Cmax) in ASP3082 (time frame: Up to 29 days). The study lists 21 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 27 Aug 2026.