About this trial
The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of combined oral contraceptive (COC) (ethinyl estradiol/levonorgestrel) in healthy female participants. This study will last approximately 35 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 (≥) 18.5 to less than or equal to ≤ 30 kilogram per square meter (kg/m²).
Adequate organ function, 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
Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])
DrugAdministered orally
Treatment groups
Trial outcomes
Primary outcomes
Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG
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 EE and LNG
PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG
Secondary outcomes
PK: Apparent Systemic Clearance (CL/F) of EE and LNG
PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of EE and LNG
PK: Time to Maximum Observed Plasma Concentration (Tmax) of EE and LNG
PK: Terminal Elimination Phase Half-Life (t1/2) of EE and LNG
Sponsors and contacts
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