NCT00959881已完成1 期
Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2009年8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
- 47
- 试验地点
- 1
- 主要终点
- Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG).
研究概览
简要总结
This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Men and women of non-childbearing potential
- •Non smoker or smoker of <10 cigarettes per day and able to refrain from smoking during study
- •18-50 years old
排除标准
- •Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- •Cardiac rhythm abnormalities
- •Family history of cardiac risk factors
研究组 & 干预措施
Donepezil plus placebo
Experimental
干预措施: Donepezil plus placebo (Drug)
Donepezil plus begacestat
Experimental
干预措施: Donepezil (Drug)
Donepezil plus begacestat
Experimental
干预措施: Begacestat (Drug)
结局指标
主要结局
Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG).
时间窗: 5 months
次要结局
- Pharmacokinetic parameters including Cmax, AUC, and t 1/2(5 months)
- Safety and tolerability as assessed by results of 12-lead ECGs, cardiac telemetry, laboratory tests, vital signs, physical examinations and reported adverse events.(5 months)
研究者
研究点 (1)
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