NCT04468815已完成1 期
An Open-Label Study to Assess Relative Bioavailability, Food Effect, and Esomeprazole Drug-Drug Interaction of BMS-986278 Tablets Following a Single Dose Administration in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年7月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of BMS-986278
研究概览
简要总结
The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
- •Women and men must agree to follow specific methods of contraception
排除标准
- •Women of childbearing potential (WOCBP) and Women who are pregnant 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
- •Exposure to any investigational drug or placebo within 4 weeks of first study treatment administration.
- •History of any significant drug and/or food allergies (such as anaphylaxis or hepatotoxicity)
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted
Experimental
干预措施: BMS-986278 Tablet (Drug)
Treatment A: BMS-986278 suspension, fasted
Experimental
干预措施: BMS-986278 suspension (Drug)
Treatment B: BMS-986278 tablet, fasted
Experimental
干预措施: BMS-986278 Tablet (Drug)
Treatment C: BMS-986278 tablet, fed
Experimental
干预措施: BMS-986278 Tablet (Drug)
Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted
Experimental
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of BMS-986278
时间窗: Up to 5 days
Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278
时间窗: Up to 5 days
Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments
时间窗: Up to 5 days
次要结局
- Incidence of Adverse Events (AEs)(Up to 29 days)
- Incidence of Serious Adverse (SAE's)(Up to 57 days)
- Incidence of AEs leading to discontinuation(Up to 29 days)
- Incidence of clinically significant changes in vital signs: Blood pressure(Up to 48 days)
- Incidence of clinically significant changes in vital signs: Heart rate(Up to 48 days)
- Incidence of clinically significant changes in vital signs: Respiratory rate(Up to 48 days)
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 48 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters(Up to 48 days)
- Incidence of clinically significant changes in physical examination findings(Up to 48 days)
- Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests(Up to 48 days)
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests(Up to 48 days)
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 48 days)
研究者
研究点 (1)
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