NCT00784420已完成1 期
Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 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
- 18
- 试验地点
- 1
- 主要终点
- Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12
研究概览
简要总结
The purpose of this study is to estimate the effect of steady state raltegravir on the steady state pharmacokinetics of UK-453,061 and steady state UK-453,061 on the steady state pharmacokinetics of raltegravir.
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
- None
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; Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication; Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
研究组 & 干预措施
UK-453,061 plus Raltegravir
Experimental
干预措施: Raltegravir (Drug)
UK-453,061
Active Comparator
干预措施: UK-453,061 (Drug)
Raltegravir
Active Comparator
干预措施: Raltegravir (Drug)
UK-453,061 plus Raltegravir
Experimental
干预措施: UK-453,061 (Drug)
结局指标
主要结局
Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12
时间窗: 11 days
UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24
时间窗: 11 days
次要结局
- Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h(11 days)
- Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments(11 days)
- UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h(11 days)
研究者
研究点 (1)
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