NCT00925535已完成1 期
Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Rifabutin And Lersivirine (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
- Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h
研究概览
简要总结
Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.
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 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.
- •History of regular alcohol consumption exceeding 7 drinks/week for women and 14 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- •Hypersensitivity/allergic reactions to any component of the study drugs.
研究组 & 干预措施
Treatment A
Active Comparator
Lersivirine
干预措施: Lersivirine (Drug)
Treatment B
Active Comparator
Rifabutin
干预措施: Rifabutin (Drug)
Treatment C
Experimental
Lersivirine and Rifabutin
干预措施: Lersivirine (Drug)
Treatment C
Experimental
Lersivirine and Rifabutin
干预措施: Rifabutin (Drug)
结局指标
主要结局
Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h
时间窗: 20 days
Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h
时间窗: 20 days
次要结局
- Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments(58 days)
研究者
研究点 (1)
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