NCT03362437已完成1 期
A Study to Evaluate the Pharmacokinetics of BMS-986177 From Form A and Form B in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年11月15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
- 12
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 18.0 to 32.0 kg/m2, inclusive
- •Women must not be of childbearing potential (cannot become pregnant)
排除标准
- •Any significant acute or chronic medical illness
- •Head injury in the last 2 years
- •History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc.
- •Other protocol defined inclusion / exclusion criteria could apply
研究组 & 干预措施
Treatment A
Experimental
Receive 200 mg BMS-986177 Form A without food
干预措施: BMS-986177 (Drug)
Treatment B
Experimental
Receive 200 mg BMS-986177 Form B without food
干预措施: BMS-986177 (Drug)
Treatment C
Experimental
Receive 200 mg BMS-986177 Form B with food
干预措施: BMS-986177 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 3 days
Measured by plasma concentration
AUC from time zero to time of last quantifiable concentration (AUC(0-T))
时间窗: Up to 3 days
Measured by plasma concentration
AUC from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to 3 days
Measured by plasma concentration
次要结局
- Incidence of Adverse Events (AEs)(Up to 12 days)
- Incidence of Serious Adverse Events (SAEs)(Up to 30 days)
- Number of participants with electrocardiogram abnormalities(Up to 12 days)
- Number of participants with physical examination abnormalities(Up to 12 days)
- Number of participants with clinical laboratory abnormalities(Up to 12 days)
研究者
研究点 (1)
Loading locations...
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