RecruitingPhase 1

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

United States24 participantsStarted 2026-06-05

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 range

18 Years – 55 Years

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 completion2026-08

Contact for this trial

Clinical Team

888-724-3274 clinicaltrials@deciphera.com

View on ClinicalTrials.gov More Healthy Participants trials

Who can participate

Age range

18 Years – 55 Years

Sex

FEMALE

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