NCT01862887已完成1 期
A Phase 1, Randomized, Placebo-And Positive-Controlled Crossover Study To Determine The Effect Of A Single-Dose Of PH-797804 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
- 48
- 试验地点
- 1
- 主要终点
- QTcF Interval
研究概览
简要总结
The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24 mg oral tablet on the QTc interval
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 subjects and/or healthy female subjects of non-child bearing potential 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 measurements, 12-lead ECG and clinical laboratory tests.
- •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
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 14 drinks/week for males.
研究组 & 干预措施
PH-797804
Experimental
Subjects will receive a single 24 mg dose in the fed state
干预措施: PH-797804 (Drug)
Moxifloxacin
Experimental
Subjects will receive a single 400 mg dose in the fed state
干预措施: Moxifloxacin (Drug)
Placebo
Experimental
Subjects will receive a single placebo dose
干预措施: Placebo (Drug)
结局指标
主要结局
QTcF Interval
时间窗: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose
QT interval corrected for heart rate using Fredericias correction
次要结局
- QTcI Interval(-1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](0,0.5,2,4,5,6,7,8,12,24 hours post-dose)
- Maximum Observed Plasma Concentration (Cmax)(0,0.5,2,4,5,6,7,8,12,24 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0,0.5,2,4,5,6,7,8,12,24 hours post-dose)
研究者
研究点 (1)
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