NCT01018368已完成1 期
An Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 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
- 入组人数
- 24
- 主要终点
- VX 770 pharmacokinetic (PK) parameters
研究概览
简要总结
The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.
详细描述
This is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to investigate the safety, tolerability and pharmacokinetics of VX 770 when administered alone or with rifampin.
All enrolled subjects will receive the same treatments and undergo the same procedures. In Period 1, subjects will receive a single dose of VX 770 on Day 1. In Period 2, subjects will receive a daily dose of rifampin on Days 1 through 10 and a single dose of VX 770 on Day 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject must be male and between 18 and 55 years of age
- •Subject must have a body mass index (BMI) from 18 to 30 kg/m2
排除标准
- •History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject
- •Subjects who have active tuberculosis, human immunodeficiency virus, hepatitis C, or active hepatitis B
研究组 & 干预措施
VX-770
Experimental
干预措施: VX-770 (Drug)
Rifampin
Experimental
干预措施: Rifampin (Drug)
结局指标
主要结局
VX 770 pharmacokinetic (PK) parameters
时间窗: 17 days
次要结局
- VX 770 metabolite PK parameters in plasma(17 days)
- Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin(17 days)
- Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments(17 days)
研究者
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