A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-581 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Part C: 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 this study is to evaluate the safety, tolerability, and pharmacokinetics of single dose of VX-581 and multiple ascending doses of VX-581 alone and in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA for up to ten days.
详细描述
The study is being conducted to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581 in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. Additionally, VX-581 will also be administered in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA for up to ten days. Note: 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
- Parallel
- 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 more than (>) 50 kg
- •Male and Female participants of non-childbearing potential
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
Part B: Multiple Ascending Dose
Participants will be randomized to receive multiple doses of VX-581.
干预措施: VX-581 (Drug)
Part A: Single Ascending Dose
Participants will be randomized to receive a single dose of VX-581.
干预措施: VX-581 (Drug)
Placebo: Part A
Participants will be randomized to receive a single dose of placebo matched to VX-581.
干预措施: Placebo (Drug)
Placebo: Part B
Participants will be randomized to receive multiple doses of placebo matched to VX-581.
干预措施: Placebo (Drug)
结局指标
主要结局
Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Day -1 up to Day 17
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Day -1 up to Day 34
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Day -1 up to Day 66
次要结局
- Part C: Maximum Observed Plasma Concentration (Cmax) of VX-581, TEZ (if administered), D-IVA and their Metabolite(s)(On Days 1, 7, and 10)
- Part C: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) Post Dose of VX-581, TEZ (if administered), D-IVA and their Metabolite(s)(On Days 1, 7, and 10)
- Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-581(From Day 1 up to Day 34)
- Part B: Maximum Observed Plasma Concentration (Cmax) of VX-581(From Day 1 up to Day 66)
- Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-581(From Day 1 up to Day 66)
- Part A: Maximum Observed Plasma Concentration (Cmax) of VX-581(From Day 1 up to Day 34)