About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
Body mass index (BMI) from greater than or equal to (≥) 18 to less than or equal to ≤ 32 kilogram per square meter (kg/m²).
Adequate organ function and blood and urine tests, as required by the protocol and as determined by Principal Investigator.
Disqualifiers
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.
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.
Trial design
Sequential
Treatments tested in this trial
Vimseltinib
DrugAdministered orally
Dabigatran
DrugAdministered orally
Treatment groups
Trial outcomes
Primary outcomes
Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Dabigatran
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
PK: AUC from Time 0 to Infinity (AUC0-∞) of Dabigatran
Secondary outcomes
Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
PK: Apparent Systemic Clearance (CL/F) of Dabigatran
Sponsors and contacts
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