Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Female and Male Subjects. Randomised, Placebo Controlled, Single-blind, Three-period Crossover Phase-I-study With Moxifloxacin as Positive Control
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
研究概览
简要总结
The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined with faldaprevir on cardiac safety parameters in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 207127 + Faldaprevir
Tablets/capsules
干预措施: BI 207127 (Drug)
BI 207127 + Faldaprevir
Tablets/capsules
干预措施: Faldaprevir (Drug)
Moxifloxacin (Avalox®)
Tablets
干预措施: Moxifloxacin (Avalox®) (Drug)
BI 207127 placebo + Faldaprevir placebo
Tablets/capsules
干预措施: BI 207127 placebo (Drug)
BI 207127 placebo + Faldaprevir placebo
Tablets/capsules
干预措施: Faldaprevir placebo (Drug)
结局指标
主要结局
Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
时间窗: 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1
Maximum mean placebo-corrected QT interval corrected for heart rate according to a parabolic population model (QTcN) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values.
次要结局
- Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment(20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1)
- Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy(20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1)
- Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy(20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1)