NCT01017666已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of BIIB014 on the Pharmacokinetics of Rosiglitazone, Warfarin, and Midazolam 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
- Biogen
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo
研究概览
简要总结
The purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects
- •Between the ages of 18 and 45, inclusive.
- •Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive
排除标准
- •Clinically significant abnormalities (as determined by the Investigator)
- •Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)
研究组 & 干预措施
Rosiglitazone 8mg PO
Experimental
Cohort 1
干预措施: BIIB014 (Drug)
Rosiglitazone 8mg PO
Experimental
Cohort 1
干预措施: Placebo (Drug)
Midazolam 2mg PO, Warfarin 25mg PO
Experimental
Cohort 2
干预措施: BIIB014 (Drug)
Midazolam 2mg PO, Warfarin 25mg PO
Experimental
Cohort 2
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo
时间窗: 24 hours (Cohort 1); 144 hours (Cohort 2)
次要结局
- Adverse Events(Duration of subject participation)
研究者
研究点 (1)
Loading locations...
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