A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Dabigatran
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vimseltinib + Dabigatran
Day 1 single dose of dabigatran, and Day 5 coadministration of dabigatran with vimseltinib.
干预措施: Dabigatran (Drug)
Vimseltinib + Dabigatran
Day 1 single dose of dabigatran, and Day 5 coadministration of dabigatran with vimseltinib.
干预措施: Vimseltinib (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Dabigatran
时间窗: 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
时间窗: Predose up to 48 Hours Post Dose
PK: AUC from Time 0 to Infinity (AUC0-∞) of Dabigatran
时间窗: Predose up to 48 Hours Post Dose
次要结局
- Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs(Baseline through Day 21)
- PK: Apparent Systemic Clearance (CL/F) of Dabigatran(Predose up to 48 Hours Post Dose)
- PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of Dabigatran(Predose up to 48 Hours Post Dose)
- PK: Time to Maximum Observed Plasma Concentration (Tmax) of Dabigatran(Predose up to 48 Hours Post Dose)
- Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Baseline through Day 21)
- Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters(Baseline through Day 21)
- PK: Terminal Elimination Phase Half-Life (t1/2) of Dabigatran(Predose up to 48 Hours Post Dose)