NCT00411073已完成1 期
A Study to Evaluate the Effect of Repeat Oral Doses of Darapladib on Cardiac Conduction as Compared to Placebo and a Single Oral Dose of Moxifloxacin
适应症
相关药物
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 QTc interval as compared to placebo and moxifloxacin
研究概览
简要总结
This is a study to assess the effects of darapladib on the cardiac conduction of the heart as compared to placebo and moxifloxacin. This a four period crossover design with each period lasting about 10 days. There will be a 7 to 10 day wash out in between each period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30
- •Signed and dated written informed consent prior to admission to the study
- •Subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
排除标准
- •cardiac abnormalities
- •history of asthma or severe allergic reactions
- •history of alcohol or drug abuse
- •use of prescription or non-prescription drugs or vitamins or herbal supplements
- •history of cholecystectomy or biliary tract disease
- •pregnant or nursing women
- •history of allergy to the study drugs
结局指标
主要结局
Change in QTc interval as compared to placebo and moxifloxacin
时间窗: throughout the study
次要结局
- Change in ECG parameters as compared to placebo and moxifloxacin(throughout the study)
研究者
研究点 (2)
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