NCT02959060已完成1 期
An Open-Label, Single-Sequence Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects
Bristol-Myers Squibb0 个研究点目标入组 16 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
- 16
- 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))
研究概览
简要总结
This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Signed Informed Consent
- •Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
- •Subjects with body mass index of 18 to 30 kg/m2, inclusive and with normal kidney function.
- •Women participants must have documented proof that they are not of childbearing potential.
- •Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of BMS-986177 treatment.
排除标准
- •Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert
- •History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.
- •Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months.
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
- •History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds
研究组 & 干预措施
BMS-986177 and Rifampin
Experimental
干预措施: BMS-986177 (Drug)
BMS-986177 and Rifampin
Experimental
干预措施: Rifampin (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))
时间窗: Days1-15
Maximum observed plasma concentration (Cmax)
时间窗: Days1-15
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Days1-15
次要结局
- Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death(Screening- until 30 days after discontinuation of dosing or subject's participation)
研究者
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