NCT00914121已完成1 期
A Single Dose, Crossover, Placebo- and Moxifloxacin- Controlled Study of the Effects of Bosutinib on Cardiac Repolarization in Healthy Adult Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 60 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Corrected QT interval, including QTcN, QTcB, and QTcF
研究概览
简要总结
The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart (cardiac repolarization)
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 (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
- •Men or women of nonchildbearing potential; 18-50 years old; healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
SKI-606 alone
干预措施: SKI-606 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
3
Active Comparator
Moxifloxacin
干预措施: Moxifloxacin (Drug)
4
Experimental
SKI-606 plus ketoconazole
干预措施: SKI-606 (Drug)
5
Placebo Comparator
Placebo plus ketoconazole
干预措施: Placebo (Drug)
结局指标
主要结局
Corrected QT interval, including QTcN, QTcB, and QTcF
时间窗: 6 weeks
次要结局
- Laboratory evaluations, Vital Sign measurements, Adverse Event reports(6 weeks)
研究者
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