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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Administered orally
Administered orally
Nucleus Network
Saint Paul, Minnesota, United States
RECRUITINGPharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG
Time frame: Predose up to 72 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 EE and LNG
Time frame: Predose up to 72 Hours Post Dose
PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
PK: Apparent Systemic Clearance (CL/F) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
PK: Terminal Elimination Phase Half-Life (t1/2) of EE and LNG
Time frame: Predose up to 72 Hours Post Dose
Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline through Day 35
Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Time frame: Baseline through Day 21
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Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
Time frame: Baseline through Day 21