NCT01594255已完成1 期
A Randomized, Partially Blinded, 4-period, Crossover Study to Assess the Effects of Single-dose AEB071 Administration (300 and 900 mg) on Electrocardiographic QT Intervals Compared to Placebo in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo.
研究概览
简要总结
This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects age 18 to 50 years (including both) of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
排除标准
- •Smokers and tobacco product users (in the previous 3 months).
- •Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
- •A marked baseline prolongation of QT/QTcF interval
- •Presence of clinically significant illness
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AEB071 300 mg
Experimental
干预措施: sotrastaurin (Drug)
AEB071 900 mg
Experimental
干预措施: sotrastaurin (Drug)
Placebo to AEB071
Placebo Comparator
干预措施: placebo to sotrastaurin (Drug)
Moxifloxacin
Active Comparator
干预措施: Avelox (Drug)
结局指标
主要结局
Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo.
时间窗: 24 hours
次要结局
- Change in concentration of exposure-response AEB071 and AEE800 (a metabolite of AEB071) concentrations compared to cardiac repolarization intervals(24 hours)
- Tolerability of 300 and 900 mg of AEB071.(72 hours)
研究者
研究点 (1)
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