A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Extension Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of VX-407 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of VX-407 in healthy participants.
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
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 meter square (kg/m^2)
- •A total body weight of greater than (>) 50 kg
- •Nonsmoker or ex-smoker for at least 3 months before screening
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 will apply.
研究组 & 干预措施
Placebo Part B
Participants will be randomized to receive placebo matched to VX-407.
干预措施: Placebo (Drug)
Part A: Single Ascending Dose
Participants will be randomized to receive a single dose of VX-407.
干预措施: VX-407 (Drug)
Placebo Part A
Participants will be randomized to receive placebo matched to VX-407.
干预措施: Placebo (Drug)
Part B: Multiple Ascending Dose
Participants will be randomized to receive multiple doses of VX-407.
干预措施: VX-407 (Drug)
结局指标
主要结局
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Enrollment up to Day 10
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Enrollment up to Day 23
次要结局
- Part A: Maximum Observed Concentration (Cmax) of VX-407 in Plasma(From Day 1 up to Day 6)
- Part B: Cmax of VX-407 in Plasma(Days 1, 7, and 14 up to Day 19)
- Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 in Plasma(From Day 1 up to Day 6)
- Part B: Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24hr) of VX-407 in Plasma(Days 1, 7, and 14 up to Day 19)
- Part A: Time Taken for VX-407 to Reach Maximum Concentration (tmax)(From Day 1 up to Day 6)
- Part B: Time Taken for VX-407 to Reach Maximum Concentration (tmax)(Days 1, 7, and 14 up to Day 19)
- Part A: Renal Clearance (CLr) of VX-407(From Day 1 up to Day 6)
- Part B: CLr of VX-407(Day 1 and Day 14)