Open-Label, Single-Sequence, Two-Cohort Study to Evaluate the Effect of Darunavir/Cobicistat and Cobicistat on BMS-626529 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529
研究概览
简要总结
This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase the systemic exposure of BMS-626529.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female
- •Nonsmoking subjects
- •Ages 18 to 50 years
- •Inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive
- •Women of childbearing potential
- •Must agree to follow instructions for methods of contraception for the duration of the study plus 34 days post-treatment completion
排除标准
- •Any history of acute or chronic medical and surgical illness.
- •Personal of family history of hemophilia A or B
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Cohort 1, Treatment A, B
Treatment A:
BMS-663068 orally twice daily (BID) on Days 1 through 4
Treatment B:
BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14
干预措施: BMS-663068 (Drug)
Cohort 1, Treatment A, B
Treatment A:
BMS-663068 orally twice daily (BID) on Days 1 through 4
Treatment B:
BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14
干预措施: Darunavir (Drug)
Cohort 1, Treatment A, B
Treatment A:
BMS-663068 orally twice daily (BID) on Days 1 through 4
Treatment B:
BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14
干预措施: Cobicistat (Drug)
Cohort 2, Treatment C, D
Treatment C:
BMS-663068 orally BID on Days 1 through 4
Treatment D:
BMS-663068 orally BID plus COBI QD on Days 5 through 14
干预措施: BMS-663068 (Drug)
Cohort 2, Treatment C, D
Treatment C:
BMS-663068 orally BID on Days 1 through 4
Treatment D:
BMS-663068 orally BID plus COBI QD on Days 5 through 14
干预措施: Cobicistat (Drug)
结局指标
主要结局
Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529
时间窗: predose and up to 12 hours post dose on Days 4 and 14
In the presence or absence of multiple doses of DRV/COBI or COBI
次要结局
未报告次要终点