NCT04301310撤回1 期
A Phase 1, Open-label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety, and Tolerability of BMS-986235 in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2020年3月9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
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of BMS-986235
研究概览
简要总结
The purpose of this study is to examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations; no significant findings in medical history.
- •Body mass index of 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening
- •Males must agree to follow specific methods of contraception, if applicable
排除标准
- •Women of childbearing potential (WOCBP)
- •Known previous exposure to BMS-986235
- •History of any significant drug allergy
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Treatment Group
Experimental
干预措施: Rifampin (Treatment B) (Drug)
Treatment Group
Experimental
干预措施: BMS-986235 (Treatment A) (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of BMS-986235
时间窗: Day 1
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235
时间窗: Day 1
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235
时间窗: Day 1
Cmax of BMS-986235 with rifampin
时间窗: Day 10
AUC(0-T) of BMS-986235 with rifampin
时间窗: Day 10
AUC(INF) of BMS-986235 with rifampin
时间窗: Day 10
次要结局
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters(Up to 41 days)
- Incidence of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))(Up to 41 days)
- Incidence of Serious Adverse Events (SAEs)(Up to 74 days)
- Incidence of clinically significant changes from baseline in physical examination findings(Up to 41 days)
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 41 days)
- Incidence of clinically significant changes in vital signs: Heart rate(Up to 41 days)
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 41 days)
- Incidence of Nonserious Adverse Events (AEs)(Up to 46 days)
- Incidence of AEs leading to discontinuation(Up to 13 days)
- Incidence of clinically significant changes in vital signs: Respiratory rate(Up to 41 days)
- Incidence of clinically significant changes in vital signs: Blood pressure(Up to 41 days)
- Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests(Up to 41 days)
研究者
研究点 (1)
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