A Phase 1, Open Label, Randomized, Crossover Study Evaluating the Relative Bioavailability and Food Effect of a VX-147 Test Tablet Formulation Compared to a Reference Tablet Formulation in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-147 Test Compared to VX-147 Reference
研究概览
简要总结
The purpose of the study is to evaluate the relative bioavailability (BA) and the effect of food on the pharmacokinetics (PK), and the safety and tolerability of VX-147 test tablet formulation.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2), inclusive
- •A total body weight greater than 50 kg
排除标准
- •History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- •Any condition possibly affecting drug absorption
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Sequence A: VX-147
Participants will receive VX-147 reference tablet under fasted condition in Treatment Period 1, then VX-147 test tablet under fed condition in Treatment Period 2, and VX-147 test tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods.
干预措施: VX-147 (Drug)
Sequence B: VX-147
Participants will receive VX-147 test tablet under fed condition in Treatment Period 1, then VX-147 test tablet under fasted condition in Treatment Period 2, and VX-147 reference tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods.
干预措施: VX-147 (Drug)
Sequence C: VX-147
Participants will receive VX-147 test tablet under fasted condition in Treatment Period 1, then VX-147 reference tablet under fasted condition in Treatment Period 2, and VX-147 test tablet under fed condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods.
干预措施: VX-147 (Drug)
结局指标
主要结局
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-147 Test Compared to VX-147 Reference
时间窗: From Day 1 up to Day 16
Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference
时间窗: From Day 1 up to Day 16
Cmax of VX-147 Test Compared Under Fed Versus Fasted State
时间窗: From Day 1 up to Day 16
AUC(0-inf) of VX-147 Test Compared Under Fed Versus Fasted State
时间窗: From Day 1 up to Day 16
次要结局
- Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious AEs(From Day -1 up to Day 27)