The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of P-glycoprotein (P-gp) substrate (dabigatran) in healthy male participants. This study will last approximately 21 days.
Eligibility
Sex
MALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
2. Body mass index (BMI) from greater than or equal to (≥) 18 to less than or equal to ≤ 32 kilogram per square meter (kg/m\^2).
3. Adequate organ function and blood and urine tests, as required by the protocol and as determined by Principal Investigator.
Exclusion Criteria:
1. History or presence of clinically significant diseases of the neurological, dermatological, renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems or history or presence of clinically significant psychiatric, immunological, endocrine, or metabolic disease as determined by Principal Investigator.
2. Unwilling or unable to comply with the requirements of the protocol.
3. Determined by Principal Investigator to be unsuitable to participate in the study for any other reason.
Primary outcome measure(s)
Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Dabigatran — Predose up to 48 Hours Post Dose
PK: Area Under the Plasma Concentration-Time Curve from Time 0 up to Time t (AUC0-t), Where t is the Last Time Point at Which the Concentration is Above the Lower Limit of Quantification of Dabigatran — Predose up to 48 Hours Post Dose
PK: AUC from Time 0 to Infinity (AUC0-∞) of Dabigatran — Predose up to 48 Hours Post Dose
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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