NCT00809289已完成1 期
A Randomized, Multiple Dose, Placebo and Active Controlled 3-way Crossover Study to Investigate the Effects of Esreboxetine on QTc Interval 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
- 发起方
- Pfizer
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers
研究概览
简要总结
This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged 18 to 55 years
- •Body mass Index of approximately 18 to 30kg/m2
- •Informed consent document signed by the subject or a legally acceptable representative
- •Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures
排除标准
- •Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening
- •Conditions possibly affecting drug absorption
- •12-lead ECg demonstrating QTc > 450ms or any other clinically significant abnormalities at screen
- •Positive urine drug screen
- •Hypersensitivity to moxifloxacin
- •Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication
研究组 & 干预措施
Two
Placebo Comparator
干预措施: placebo (Drug)
One
Experimental
干预措施: esreboxetine (Drug)
Three
Active Comparator
Administration of a single oral dse of 400mg moxifloxacin
干预措施: moxifloxacin (Drug)
结局指标
主要结局
To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers
时间窗: Up to 24 hours
次要结局
- To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval(Up to 24 hours)
- To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers(Up to 24 hours)
研究者
研究点 (1)
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