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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG [Срок оценки: 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 [Срок оценки: Predose up to 72 Hours Post Dose]
• PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG [Срок оценки: Predose up to 72 Hours Post Dose]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Nucleus Network — Saint Paul

Идентификаторы

NCT: NCT07539090 · DCC-3014-01-010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗