An Open-label 3×3 Cross-over Study to Compare Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of Single Doses of BMS-986165 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
研究概览
简要总结
The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
- •Male and female paritcipants, aged 18 years, or age of majority, to age 55 years, inclusive
- •All female subjects must have a negative serum or urine pregnancy test
排除标准
- •Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
- •History of administration of live vaccines within 60 days before screening until clinic discharge
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- •Other protocol-defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Treatment A: BMS-986165 alone, fasted
干预措施: BMS-986165 (Drug)
Treatment B: BMS-986165 alone, fed
干预措施: BMS-986165 (Drug)
Treatment C: BMS-986165 with famotidine pretreatment, fasted
干预措施: BMS-986165 (Drug)
Treatment C: BMS-986165 with famotidine pretreatment, fasted
干预措施: Famotidine (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
时间窗: Day 1 to Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for a tablet dosed with high-fat high-calorie meal versus fasted condition
时间窗: Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
时间窗: Day 1 to Day 13
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
时间窗: Day 1 to Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
时间窗: Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
时间窗: Day 1 to Day 13
次要结局
- Incidence of Adverse Events (AEs)(Up to 39 days)
- Number of clinically significant changes in electrocardiogram (ECG) parameters(Up to 18 days)
- Number of clinically significant changes in vital sign measurements(Up to 18 days)
- Number of clinically significant changes in clinical laboratory test results(Up to 18 days)