A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Maraviroc Pharmacokinetics: Cmax
研究概览
简要总结
This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 a total of 34 days post-treatment completion
排除标准
- •Any condition possibly affecting drug absorption
- •Pre-existing liver dysfunction
- •Any significant acute or chronic medical illness
- •Orthostatic intolerance
- •Other protocol specified exclusion criteria could apply
研究组 & 干预措施
Sequential Dosing
Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18
干预措施: BMS-663068 (Drug)
Sequential Dosing
Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18
干预措施: Maraviroc (Drug)
结局指标
主要结局
Maraviroc Pharmacokinetics: Cmax
时间窗: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
PK parameters for maraviroc in the absence or presence of BMS-663068 include: - Cmax
BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax)
时间窗: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - Cmax
BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU)
时间窗: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - AUC(TAU)
Maraviroc Pharmacokinetics: AUC(TAU)
时间窗: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
PK parameters for maraviroc in the absence or presence of BMS-663068 include: - AUC(TAU)
次要结局
- Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12)(predose and up to 12 hours post dose on Days 4, 16, 17, and 18)
- Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose)(predose and up to 12 hours post dose on Days 4, 16, 17, and 18)
- Other PK Parameters for maraviroc: C12(predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18)
- Other PK Parameters for maraviroc: Ctrough(predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18)
- Clinical Safety as Measured by Adverse Events(Day 1 to Day 26)
- Other PK Parameters for maraviroc: Tmax(predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18)
- Clinical Safety as Measured by Vital Signs(Day 1 to Day 26)
- Clinical Safety as Measured by Electrocardiograms (ECGs)(Day 1 to Day 26)
- Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax)(predose and up to 12 hours post dose on Days 4, 16, 17, and 18)
- Clinical Safety as Measured by Physical Examination(Day 1 to Day 26)
- Clinical Safety as Measured by Clinical Laboratory Evaluations(Day 1 to Day 26)