Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants

Официальное название

A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants

Обзор

The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of P-glycoprotein (P-gp) substrate (dabigatran) in healthy male participants. This study will last approximately 21 days.

Вмешательства

• Препарат Vimseltinib
  Administered orally
• Препарат Dabigatran
  Administered orally

Первичные конечные точки

• Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Dabigatran [Срок оценки: Predose up to 48 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 Dabigatran [Срок оценки: Predose up to 48 Hours Post Dose]
• PK: AUC from Time 0 to Infinity (AUC0-∞) of Dabigatran [Срок оценки: Predose up to 48 Hours Post Dose]

Вторичные конечные точки (7)

• Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: Baseline through Day 21]
• 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]
• PK: Apparent Systemic Clearance (CL/F) of Dabigatran [Срок оценки: Predose up to 48 Hours Post Dose]
• PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of Dabigatran [Срок оценки: Predose up to 48 Hours Post Dose]
• PK: Time to Maximum Observed Plasma Concentration (Tmax) of Dabigatran [Срок оценки: Predose up to 48 Hours Post Dose]
• PK: Terminal Elimination Phase Half-Life (t1/2) of Dabigatran [Срок оценки: Predose up to 48 Hours Post Dose]

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 to less than or equal to ≤ 32 kilogram per square meter (kg/m\^2).
• Adequate organ function and 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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07744802 · DCC-3014-01-009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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