NCT01060566已完成1 期
An Open-Label Phase 1 Study to Examine the Effect of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on 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
- 试验地点
- 1
- 主要终点
- Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter
研究概览
简要总结
The objectives of this study are to evaluate the effects of VX-770 on Midazolam and Rosiglitazone, and the effect of Fluconazole on VX-770.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be male or female and between 18 and 55 years of age.
- •Subjects must be judged to be in good health.
- •Subjects must have a body mass index (BMI) from 18 to 30 kg/m2.
排除标准
- •History of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
- •Subjects who have human immunodeficiency virus (HIV), hepatitis C, or active hepatitis B.
- •Female subjects and female partner(s) of male subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug.
- •History of cardiovascular disease, hypoglycemia, or edema.
研究组 & 干预措施
VX-770
Experimental
干预措施: VX-770 (Drug)
Midazolam
Experimental
干预措施: VX-770 (Drug)
Rosiglitazone
Experimental
干预措施: VX-770 (Drug)
Fluconazole
Experimental
干预措施: VX-770 (Drug)
结局指标
主要结局
Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter
时间窗: 11 days
Fluconazole and VX 770 PK parameters
时间窗: 10 days
次要结局
- 1´ hydroxy midazolam PK parameters in plasma(11 days)
- Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments(21 days)
- Metabolites PK parameters in plasma(21 days)
研究者
研究点 (1)
Loading locations...
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