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

April 29, 2026 updated by: Deciphera Pharmaceuticals, LLC

A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) in Healthy Female Participants

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Recruiting
        • Nucleus Network
        • Contact:
        • Principal Investigator:
          • Emmanuel Ferrer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Vimseltinib
Administered orally
Drug: Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG
Time Frame: Predose up to 72 Hours Post Dose
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
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
Predose up to 72 Hours Post Dose

Secondary Outcome Measures

Outcome Measure
Time Frame
PK: Apparent Systemic Clearance (CL/F) of EE and LNG
Time Frame: Predose up to 72 Hours Post Dose
Predose up to 72 Hours Post Dose
PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of EE and LNG
Time Frame: Predose up to 72 Hours Post Dose
Predose up to 72 Hours Post Dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of EE and LNG
Time Frame: Predose up to 72 Hours Post Dose
Predose up to 72 Hours Post Dose
PK: Terminal Elimination Phase Half-Life (t1/2) of EE and LNG
Time Frame: Predose up to 72 Hours Post Dose
Predose up to 72 Hours Post Dose
Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline through Day 35
Baseline through Day 35
Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Time Frame: Baseline through Day 21
Baseline through Day 21
Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
Time Frame: Baseline through Day 21
Baseline through Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deciphera Pharmaceuticals, LLC

Investigators

  • Study Director: Clinical Team, Deciphera Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCC-3014-01-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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