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
Sex
FEMALE
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 (≥) 18.5 to less than or equal to ≤ 30 kilogram per square meter (kg/m\^2).
3. Adequate organ function, 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 EE and LNG — 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 — Predose up to 72 Hours Post Dose
PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG — Predose up to 72 Hours Post Dose
Trial sites (1)
Facility
City
Region
Status
Nucleus Network
Saint Paul
Minnesota
Recruiting
More Deciphera Pharmaceuticals, LLC trials in the USA
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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