NCT00936871已完成1 期
A Phase 1, Randomized, Single Dose, Placebo And Active Controlled, 3-Way Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects
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
- 66
- 试验地点
- 1
- 主要终点
- (Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
研究概览
简要总结
This study has been designed to investigate the effect of lersivirine on the QT/QTc interval in order to help establish the safety profile of lersivirine.
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
- Single (Participant)
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/or female subjects between the ages of 18 and 55 years, inclusive, (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, normal 12-lead ECG and clinical laboratory tests)
排除标准
- •History of risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction).
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day
- •Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication.
研究组 & 干预措施
Part A
Experimental
Lersivirine Tolerability
干预措施: Lersivirine (Drug)
Part A
Experimental
Lersivirine Tolerability
干预措施: Placebo (Drug)
Part A
Experimental
Lersivirine Tolerability
干预措施: Lersivirine (if necessary) (Drug)
Part B
Experimental
Thorough QTc
干预措施: Lersivirine (Drug)
Part B
Experimental
Thorough QTc
干预措施: Placebo (Drug)
Part B
Experimental
Thorough QTc
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
(Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
时间窗: 1 day
(Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo.
时间窗: 3 days
次要结局
- To determine study sensitivity by comparing the effect of moxifloxacin on QTc relative to time-matched placebo, at the historical moxifloxacin Tmax of 3 hours.(1 day)
- To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.(1 day)
- To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine.(1 day)
- To assess the single dose pharmacokinetics of lersivirine.(1 - 2 days)
研究者
研究点 (1)
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