NCT07539090

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
1mo left

Started May 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
May 2026Jun 2026

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 13, 2026

Last Update Submit

April 29, 2026

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

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

    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

    Predose up to 72 Hours Post Dose

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

    Predose up to 72 Hours Post Dose

Secondary Outcomes (7)

  • PK: Apparent Systemic Clearance (CL/F) of EE and LNG

    Predose up to 72 Hours Post Dose

  • PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of EE and LNG

    Predose up to 72 Hours Post Dose

  • PK: Time to Maximum Observed Plasma Concentration (Tmax) of EE and LNG

    Predose up to 72 Hours Post Dose

  • PK: Terminal Elimination Phase Half-Life (t1/2) of EE and LNG

    Predose up to 72 Hours Post Dose

  • Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Baseline through Day 35

  • +2 more secondary outcomes

Study Arms (1)

Vimseltinib + Combined Oral Contraceptive (COC)

EXPERIMENTAL

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

Interventions

VimseltinibDRUG

Administered orally

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

Administered orally

Vimseltinib + Combined Oral Contraceptive (COC)

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network

Saint Paul, Minnesota, 55114, United States

RECRUITING

MeSH Terms

Interventions

Contraceptives, Oral, CombinedEthinyl Estradiol

Intervention Hierarchy (Ancestors)

Drug CombinationsPharmaceutical PreparationsContraceptives, OralContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesNorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Clinical Team

    Deciphera Pharmaceuticals, LLC

    STUDY DIRECTOR

Central Study Contacts

Clinical Team

CONTACT

888-724-3274clinicaltrials@deciphera.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)