A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, Thorough QT/QTc Study of Vanzacaftor Monotherapy in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 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 this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 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), both inclusive
- •Male and female participants of age 18 to 45 years, both inclusive
- •Serum potassium, calcium, and magnesium values within normal ranges
排除标准
- •Median QTcF>450 msec on triplicate 12-lead ECGs
- •History of conduction abnormalities
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Group 1
Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points.
干预措施: Vanzacaftor (Drug)
Group 1
Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points.
干预措施: Vanzacaftor Placebo (Drug)
Group 1
Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points.
干预措施: Moxifloxacin Placebo (Drug)
Group 2A
Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points.
干预措施: Vanzacaftor Placebo (Drug)
Group 2A
Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points.
干预措施: Moxifloxacin (Drug)
Group 2A
Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points.
干预措施: Moxifloxacin Placebo (Drug)
Group 2B
Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.
干预措施: Vanzacaftor Placebo (Drug)
Group 2B
Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.
干预措施: Moxifloxacin (Drug)
Group 2B
Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin 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 23
次要结局
- Change in QRS duration(From Baseline up to Day 23)
- Placebo-corrected Change in QTcF(From Baseline up to Day 23)
- Placebo-corrected Change in HR(From Baseline up to Day 23)
- Placebo-corrected Change in PR interval(From Baseline up to Day 23)
- Placebo-corrected Change in QRS duration(From Baseline up to Day 23)
- Number of Outliers for QTcF(From Baseline up to Day 23)
- Number of Outliers for HR(From Baseline up to Day 23)
- Number of Outliers for PR interval(From Baseline up to Day 23)
- Number of Outliers for QRS duration(From Baseline up to Day 23)
- Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence(From Baseline up to Day 23)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day -2 up to Day 38)
- Maximum Observed Plasma Concentration (Cmax) of VNZ(Days 11 and 21)
- Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ(Days 11 and 21)
- Time Taken for VNZ to Reach Maximum Concentration (tmax)(Days 11 and 21)
- Change in Heart Rate (HR)(From Baseline up to Day 23)
- Change in PR interval, segment(From Baseline up to Day 23)