A Phase 1, Randomized, Double-blind, Placebo- and Active-controlled, Thorough QT/QTc Study of VX-548 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in QT interval corrected by Fridericia's formula (QTcF)
研究概览
简要总结
The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite.
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
- 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 greater than (>) 50 kilogram (kg)
排除标准
- •History of febrile illness within 5 days before the first dose of study drug
- •Any condition possibly affecting drug absorption
- •Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Group 2B
Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.
干预措施: VX-548 Placebo (Drug)
Group 2A
Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points.
干预措施: VX-548 Placebo (Drug)
Group 1
Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points.
干预措施: VX-548 Placebo (Drug)
Group 2A
Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points.
干预措施: Moxifloxacin Placebo (Drug)
Group 1
Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points.
干预措施: VX-548 (Drug)
Group 2B
Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.
干预措施: Moxifloxacin Placebo (Drug)
Group 2A
Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points.
干预措施: Moxifloxacin (Drug)
Group 2B
Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.
干预措施: Moxifloxacin (Drug)
Group 1
Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points.
干预措施: Moxifloxacin Placebo (Drug)
结局指标
主要结局
Change in QT interval corrected by Fridericia's formula (QTcF)
时间窗: From Baseline up to Day 12
次要结局
- Change in QRS duration(From Baseline up to Day 12)
- Change in Heart Rate (HR)(From Baseline up to Day 12)
- Change in PR interval, segment(From Baseline up to Day 12)
- Placebo-corrected Change in PR interval(From Baseline up to Day 12)
- Placebo-corrected Change in QRS duration(From Baseline up to Day 12)
- Number of Outliers for PR interval(From Baseline up to Day 12)
- Number of Outliers for QRS duration(From Baseline up to Day 12)
- Placebo-corrected Change in QTcF(From Baseline up to Day 12)
- Placebo-corrected Change in HR(From Baseline up to Day 12)
- Number of Outliers for QTcF(From Baseline up to Day 12)
- Number of Outliers for HR(From Baseline up to Day 12)
- Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence(From Baseline up to Day 12)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 26)
- Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite(Days 6 and 10: Pre-dose up to 24 hours)
- Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite(Days 6 and 10: Pre-dose up to 24 hours)