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NCT Number: NCT07539090

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location status: Recruiting

Location contact

Emmanuel Ferrer, MD

PRINCIPAL_INVESTIGATOR

Jennifer Bookey

CONTACT

[email protected]

651-641-2900

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vimseltinib

Drug

Administered orally

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

Drug

Administered orally

Primary outcomes

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

    Time frame: Predose up to 72 Hours Post Dose

  2. 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

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

    Time frame: Predose up to 72 Hours Post Dose

Secondary outcomes

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

    Time frame: Predose up to 72 Hours Post Dose

  2. 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

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

    Time frame: Predose up to 72 Hours Post Dose

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

    Time frame: Predose up to 72 Hours Post Dose

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

    Time frame: Baseline through Day 35

  6. Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters

    Time frame: Baseline through Day 21

  7. Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs

    Time frame: Baseline through Day 21

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Team

CONTACT

[email protected]

888-724-3274

Sponsors and collaborators

Lead sponsor

Deciphera Pharmaceuticals, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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