Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)

Deciphera Pharmaceuticals, LLC

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG]); Drug: Vimseltinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07539090

DCC-3014-01-010

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Vimseltinib + Combined Oral Contraceptive (COC)

Experimental group

Description:

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.

Treatment:

Drug: Vimseltinib

Drug: Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])