A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human 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
- 已完成
- 入组人数
- 159
- 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 pharmacokinetic parameters 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 may apply.
研究组 & 干预措施
Part A: Single Ascending Dose (SAD)
Participants will be randomized to receive a single dose of different dose levels of VX-407.
干预措施: VX-407 (Drug)
Part A: Placebo
Participants will be randomized to receive placebo matched to VX-407.
干预措施: Placebo (Drug)
Part B: Multiple Ascending Dose (MAD)
Participants will be randomized to receive multiple doses of different dose levels of VX-407. The dose levels will be determined based on the data from Part A.
干预措施: VX-407 (Drug)
Part B: Placebo
Participants will be randomized to receive multiple doses of placebo matched to VX-407.
干预措施: Placebo (Drug)
Part C: Drug-Drug Interaction
Participants will be administered Midazolam (MDZ) in the presence or absence of VX-407. The dose levels will be determined based on the data from Part B.
干预措施: VX-407 (Drug)
Part C: Drug-Drug Interaction
Participants will be administered Midazolam (MDZ) in the presence or absence of VX-407. The dose levels will be determined based on the data from Part B.
干预措施: Midazolam (Drug)
Part D
Participants will be randomized to receive VX-407 in 1 of 3 treatment sequences with 3 dosing periods to assess the relative bioavailability of VX-407 formulations and the effect of food on the pharmacokinetics 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 Plasma Concentration (Cmax) of VX-407(From Day 1 up to Day 6)
- Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407(Days 1, 7, and 14)
- Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407(On Day 1, and Day 15)
- Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407(Days 1, 7, and 14)
- Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Enrollment up to Day 24)
- Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407(From Day 1 up to Day 6)
- Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407(On Day 1, and Day 15)
- Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation (test) compared to a Suspension Formulation (reference) Under Fasted Conditions(Days 1, 7, and 13)
- Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation Under Fed versus Fasted State(Days 1, 7, and 13)
- Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 Under Fasted Conditions(Days 1, 7, and 13)
- Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 Tablet Formulation Under Fed versus Fasted State(Days 1, 7, and 13)
- Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Enrollment up to Day 22)