Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
Part of paid clinical trials in Saint Paul, Minnesota.
- Sponsor
- Deciphera Pharmaceuticals, LLC
- Study ID
- NCT07539090
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Healthy Participants
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Vimseltinib — DRUGAdministered orally
- Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG]) — DRUGAdministered orally
Study Details
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.
Key Dates
- Start date
- Jun 5, 2026
- Status verified
- Jun 2026
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Vimseltinib + Combined Oral Contraceptive (COC)Day 1 single dose of combined oral contraceptive (COC) (ethinyl estradiol \[EE\]/levonorgestrel \[LNG\]). Day 4 through 7, Day 11 and Day 14 single daily dose of Vimseltinib. Day 18 coadministration of COC (EE /LNG) with vimseltinib.
Primary Outcome Measure
Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG [ Time Frame: Predose up to 72 Hours Post Dose ]
Central Contacts
- Clinical Team888-724-3274
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nucleus Network | Saint Paul | Minnesota | 55114 | Emmanuel Ferrer, MD (PRINCIPAL_INVESTIGATOR) |
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