RecruitingPhase 1

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

United States24 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG

Timeframe: 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

Timeframe: Predose up to 72 Hours Post Dose

PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG

Timeframe: Predose up to 72 Hours Post Dose

Trial details

NCT IDNCT07539090

SponsorDeciphera Pharmaceuticals, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Clinical Team

888-724-3274 clinicaltrials@deciphera.com

View on ClinicalTrials.gov More Healthy Participants trials

Who can participate

Age range18 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG

Timeframe: Predose up to 72 Hours Post Dose

PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG

Timeframe: Predose up to 72 Hours Post Dose