Assessment of the Effect of 25 mg and 200 mg of BI 10773 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Five-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
- 30
- 试验地点
- 1
- 主要终点
- Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing
研究概览
简要总结
The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo
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
- Double
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 10773
single oral (high and low) dose per subject
干预措施: BI 10773 (low) (Drug)
BI 10773
single oral (high and low) dose per subject
干预措施: BI 10773 (high) (Drug)
Placebo
2 single oral doses per subject
干预措施: BI 10773 Placebo (Drug)
Moxifloxacin
single oral dose per subject
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing
时间窗: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose
Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg. Note, the treatment means presented are actually adjusted means.
Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing
时间窗: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose
Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg. Note, the treatment means presented are actually adjusted means.
次要结局
- Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing(60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose)
- Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing(60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose)
- Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing(60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose)
- Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings(60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose)
- Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings(60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose)