NCT04124003已完成1 期
An Open-label, Single-sequence, Drug-drug Interaction Study to Assess the Effect of BMS-963272 Coadministration on the Systemic Exposure of Rosuvastatin in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年10月8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
- 28
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve extrapolated to infinity AUC (INF)
研究概览
简要总结
Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in 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
- Diagnostic
- 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 medical history, physical examination, ECGs, and clinical laboratory determinations
- •Women must not be of childbearing potential (WNOCBP)
- •Women and men must agree to follow instructions for methods of contraception
排除标准
- •Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study.
- •Any major surgery within 4 weeks of study drug administration
- •Any blood transfusion or donation of blood to a blood bank or in a clinical study within 4 weeks of study drug administration
- •Previous treatment with BMS-963272
- •Participants who smoke, as well as, those who have stopped smoking less than 6 months prior to day 1
- •Other protocol-defined inclusion/exclusion criteria could apply
研究组 & 干预措施
rosuvastatin + BMS-963272
Experimental
干预措施: rosuvastatin (Drug)
rosuvastatin + BMS-963272
Experimental
干预措施: BMS-963272 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve extrapolated to infinity AUC (INF)
时间窗: up to Day 10
Maximum concentration (Cmax)
时间窗: up to Day 10
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T)
时间窗: up to Day 10
次要结局
- Incidence of Adverse Events (AEs)(Approximately 50 days)
- Number of significant changes in lab assessments of urine(Approximately 50 days)
- Blood pressure(Approximately 50 days)
- Number of significant changes in lab assessments of blood(Approximately 50 days)
- Number of significant changes in lab assessments of blood serum(Approximately 50 days)
- Body temperature(Approximately 50 days)
- Respiratory rate(Approximately 50 days)
- Number of Participants with abnormal physical examination findings(Approximately 50 days)
- Heart rate(Approximately 50 days)
- Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities(Approximately 50 days)
研究者
研究点 (1)
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