NCT02439190已完成1 期
A Single Dose Study to Evaluate the Effect of BMS-986120 on Thrombus Formation in an Ex Vivo Thrombosis Chamber Model in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年9月最近更新:
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
- 42
- 试验地点
- 1
- 主要终点
- Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment)
研究概览
简要总结
The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and clopidogrel decrease blood clotting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
- •Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive. BMI = weight (kg)/ [height (m)]2
- •Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 65, inclusive
- •Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section
排除标准
- •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
- •Any condition that could affect drug absorption
- •Other protocol-defined exclusion criteria could apply
研究组 & 干预措施
Treatment A: BMS-986120
Active Comparator
BMS-986120 on specified days
干预措施: BMS-986120 (Drug)
Treatment B: Aspirin and Clopidogrel
Active Comparator
Aspirin and Clopidogrel on specified days
干预措施: Aspirin (Drug)
Treatment B: Aspirin and Clopidogrel
Active Comparator
Aspirin and Clopidogrel on specified days
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment)
时间窗: 2 days
次要结局
- Safety and tolerability of BMS 986120 or aspirin administered with and without clopidogrel based on adverse events,clinical laboratory tests, physical examinations and vital signs per the collection schedule(2 days)
研究者
研究点 (1)
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