A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of VX-993 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 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 this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-993 at different doses 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 more than (>) 50 kg
- •Participants of non-childbearing potential
- •Nonsmoker or ex-smoker for at least 3 months before screening
排除标准
- •History of febrile illness or other acute illness 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-993.
干预措施: VX-993 (Drug)
Part B: Multiple Ascending Dose (MAD)
Participants will be randomized to receive multiple doses of different dose levels of VX-993. The dose levels will be determined based on the data from Part A.
干预措施: VX-993 (Drug)
Placebo Part A
Participants will be randomized to receive placebo matched to VX-993.
干预措施: Placebo (Drug)
Placebo Part B
Participants will be randomized to receive multiple doses of placebo matched to VX-993.
干预措施: Placebo (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: Day 1 up to Day 25
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Day 1 up to Day 25
Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
时间窗: Pre-dose up to Day 25
次要结局
- Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993(Pre-dose up to Day 25)
- Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993(Pre-dose up to Day 25)
- Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993(Pre-dose up to Day 25)
- Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993(Pre-dose up to Day 25)
- Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test(Day 1, Day 10, and Day 11)