RecruitingPhase 1NCT07539090
Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) in Healthy Female Participants
Sponsor
Deciphera Pharmaceuticals, LLC
Enrollment
24 participants
Start Date
May 1, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
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: FEMALEMin Age: 18 YearsMax Age: 55 Years
Inclusion Criteria3
- 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/m\^2).
- Adequate organ function, blood and urine tests, as required by the protocol and as determined by Principal Investigator.
Exclusion Criteria3
- 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.
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Interventions
DRUGVimseltinib
Administered orally
DRUGCombined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])
Administered orally
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07539090
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