Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2)
Not Applicable
Not yet recruiting
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT07158411
- Lead Sponsor
- Deciphera Pharmaceuticals, LLC
- Brief Summary
The main purpose of this study is to evaluate the effect of multiple doses of vimseltinib on the pharmacokinetics (PK) of a clinical OCT2 substrate (metformin) in healthy male participants. This study will also assess the safety and tolerability when vimseltinib is co-administered with the clinical OCT2 substrate (metformin) in healthy male participants. This study will last approximately 25 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
- Body mass index (BMI) from 18 to 32 kilogram per square meter (kg/m^2).
- Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
- Adequate organ function and blood and urine tests, as required by the protocol and as determined by Principal Investigator.
Exclusion Criteria
- History or presence of clinically significant diseases of the neurological, dermatological, renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems and/or history or presence of clinically significant psychiatric, immunological, endocrine, or metabolic disease in the opinion of the Investigator.
- Unwilling or unable to comply with the requirements of the protocol.
- Determined by Principal Investigator to be unsuitable to participate in the study for any other reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Metformin + Vimseltinib Vimseltinib Metformin as single dose will be administered on Day 1 and Day 6. Vimseltinib will be administered every day (QD) on Days 3 through 6 Metformin + Vimseltinib Metformin Metformin as single dose will be administered on Day 1 and Day 6. Vimseltinib will be administered every day (QD) on Days 3 through 6
- Primary Outcome Measures
Name Time Method Pharmacokinetic (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Metformin Predose up to 48 hours postdose PK: Area Under the Concentration Versus Time Curve (AUC) of Metformin Predose up to 48 hours postdose
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Baseline through Day 25