NCT01140425已完成1 期
A Phase 1, Randomized, Multiple Dose, Placebo And Active Controlled, 4-Way Crossover Study To Evaluate The Effect Of A Multiple Oral Dose of PF-00232798 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
- 44
- 试验地点
- 1
- 主要终点
- QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7.
研究概览
简要总结
The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias.
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
- 21 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 of non-childbearing potential between the ages of 21 and 55 years, inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- •12-lead ECG demonstrating QTc >450 msec at screening.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- •History of orthostatic symptoms or orthostatic hypotension at screening.
- •Pregnant or nursing females; females of childbearing potential.
研究组 & 干预措施
PF-00232798 supratherapeutic dose
Experimental
PF-00232798 supratherapeutic dose
干预措施: PF-00232798 (Drug)
PF-00232798 therapeutic dose
Experimental
PF-00232798 therapeutic dose
干预措施: PF-00232798 (Drug)
Placebo for PF-00232798
Placebo Comparator
Placebo for PF-00232798
干预措施: Placebo (Drug)
Moxifloxacin
Active Comparator
Moxifloxacin
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7.
时间窗: 7 days
次要结局
- QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin on Day 7(7 days)
- Pharmacokinetic endpoints for PF-00232798 (Tmax, Cmax, Cτ, and AUClast)(7 days)
- Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments(7 days)
- QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7(7 days)
研究者
研究点 (1)
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