A Drug-Drug Interaction Study to Assess the Effect of Rifampin on the Pharmacokinetics of an Oral Dose of BMS-986278 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) for BMS-986278
研究概览
简要总结
The purpose of this study is to investigate the effects of experimental medication BMS-986278 given with the antibiotic Rifampin in healthy participants.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening
排除标准
- •Women who are of childbearing potential or breastfeeding
- •Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
- •History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
- •History of significant cardiovascular disease
- •Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986278 + Rifampin
Treatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278
干预措施: BMS-986278 (Drug)
BMS-986278 + Rifampin
Treatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278
干预措施: Rifampin (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) for BMS-986278
时间窗: Day 1 and 8
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278
时间窗: Day 1 and 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for BMS-986278
时间窗: Up to 24 days
Terminal phase half-life (T-HALF) for BMS-986278
时间窗: Day 1 and 8
次要结局
- Incidence of non-serious adverse events (AE)(Up to 24 days)
- Incidence of serious adverse events (SAE)(Up to 24 days)
- Incidence of AE leading to discontinuation(Up to 24 days)
- Incidence of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests(Up to 24 days)
- Maximum observed plasma concentration (Cmax) for Rifampin(Day 8)
- Time of maximum observed plasma concentration (Tmax) for Rifampin(Day 8)
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for Rifampin(Day 8-9)
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for Rifampin(Day 8-9)