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

Official 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

Overview

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.

Interventions

• Drug Vimseltinib
  Administered orally
• Drug Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])
  Administered orally

Primary outcome measures

• 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]

Secondary outcome measures (7)

• PK: Apparent Systemic Clearance (CL/F) of EE and LNG [Time frame: 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]
• PK: Time to Maximum Observed Plasma Concentration (Tmax) of EE and LNG [Time frame: 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]
• Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Baseline through Day 35]
• Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters [Time frame: Baseline through Day 21]
• Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs [Time frame: Baseline through Day 21]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Nucleus Network — Saint Paul

Identifiers

NCT: NCT07539090 · DCC-3014-01-010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗