NCT03979248已完成1 期
An Open-Label, Single-Sequence Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole on the Pharmacokinetics of BMS-986165 in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2019年5月16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
- 21
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) of BMS-986165
研究概览
简要总结
The purpose of this study is to evaluate the effects of stomach acid suppression by rabeprazole and BMS-986165 on how fast and complete the drug is absorbed into the body of healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- •Any major surgery within 4 weeks of study drug administration
- •Use of any prescription drugs or over-the-counter acid controllers
- •Positive urine screen for drugs of abuse, alcohol, or cotinine
- •History of allergy to BMS-986165, rabeprazole, or related compounds
- •Other protocol inclusion/exclusion criteria may apply.
研究组 & 干预措施
BMS-986165 + Rabeprazole
Experimental
干预措施: BMS-986165 (Drug)
BMS-986165 + Rabeprazole
Experimental
干预措施: Rabeprazole (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) of BMS-986165
时间窗: Day 1 and Day 9
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986165
时间窗: Day 1 and Day 9
Maximum Observed Plasma Concentration (Cmax) of BMS-986165
时间窗: Day 1 and Day 9
次要结局
- Percentage of Participants with Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs)(Up to Day 12)
- Percentage of Participants with Adverse Events (AEs)(Up to Day 12)
研究者
研究点 (1)
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