Recruiting
Phase 1

Vimseltinib with COC

Sponsor:

Deciphera Pharmaceuticals, LLC

Code:

NCT07539090

Conditions

Healthy Participants

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Vimseltinib

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

Study Details

Brief 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.

Conditions

Healthy Participants

Study ID

NCT07539090

Start date

Jun 5, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Vimseltinib

Administered orally

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

Administered orally

Primary outcome measure

  • Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG [ Time Frame: 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 [ Time Frame: Predose up to 72 Hours Post Dose ]
  • PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG [ Time Frame: Predose up to 72 Hours Post Dose ]

Central Contacts and Locations

Central contacts

Clinical Team

888-724-3274clinicaltrials@deciphera.com

Locations

Nucleus Network

Recruiting

Saint Paul, Minnesota, United States, 55114

Contacts

Jennifer Bookey

651-641-2900j.bookey@nucleusnetwork.com

Principal Investigator:

Emmanuel Ferrer, MD

More Information

Sponsor

Deciphera Pharmaceuticals, LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Deciphera Pharmaceuticals, LLC on 2026-09-03.