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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorDeciphera Pharmaceuticals, LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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/m²).

Adequate organ function, blood and urine tests, as required by the protocol and as determined by Principal Investigator.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Vimseltinib

    Drug

    Administered orally

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

    Drug

    Administered orally

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Vimseltinib + Combined Oral Contraceptive (COC)Experimental treatment 2 interventions

Trial outcomes

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

Other outcomes

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