NCT02902679已完成1 期
An Open-label Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2016年11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
- 6
- 试验地点
- 1
- 主要终点
- To assess the Change from baseline in Physical examination parameters.
研究概览
简要总结
An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants before and after a hemodialysis session to evaluate safety, tolerability, and pharmacokinetics in this patient population.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Classified at screening as having ESRD requiring hemodialysis at least 3 times per week for 3 months.
- •Clinical, ECG, and laboratory findings consistent with renal dysfunction
- •BMI of 18.0 to 38.0 kg/m2 inclusive
- •Subjects must receive unfractionated heparin during dialysis treatments and are able to withstand a decrease in their established heparin dose (75% of current dose)
- •Women Not of child bearing potential (WNOCBP). Sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control
排除标准
- •History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
- •Evidence or history of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising
- •Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery that could interfere with absorption of study drug
- •Any condition requiring anticoagulation such as, but not limited to, atrial fibrillation, mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism (other than heparin required during hemodialysis)
- •Need for aspirin or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
End Stage Renal Disease Subjects
Experimental
Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session
干预措施: BMS-986177 (Drug)
结局指标
主要结局
To assess the Change from baseline in Physical examination parameters.
时间窗: Day -1 - day 3
To assess the change from baseline in Electrocardiogram (ECG) assessment.
时间窗: Day -1 - day 3
To assess the change from baseline in clinical laboratory values.
时间窗: Day -1 - day 3
To assess the change from baseline in vital signs assessment.
时间窗: Day -1 - day 3
To assess the Number of subjects with Adverse events (AEs).
时间窗: Day -1 - day 3
次要结局
- To assess the change from baseline in activated partial thromboplastin time (aPTT).(Day -1 - day 3)
- To assess the change from baseline in Factor XI clotting activity (FX1c ).(Day -1 - day 3)
研究者
研究点 (1)
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