NCT04671953已完成1 期
An Open-label, Two-arm Crossover Study to Investigate the Effect of BMS-986165 on the Pharmacokinetics of Metformin in Healthy Volunteers
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年12月18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
- 36
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) in plasma for metformin with and without BMS-986165
研究概览
简要总结
The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, as determined by having no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory determinations
- •Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
- •Must agree to follow specific methods of contraception, if applicable
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, including a history of or active liver disease
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm 1: BMS-986165 Dose 1 + Metformin
Experimental
干预措施: BMS-986165 (Drug)
Arm 1: BMS-986165 Dose 1 + Metformin
Experimental
干预措施: Metformin (Drug)
Arm 2: BMS-986165 Dose 2 + Metformin
Experimental
干预措施: BMS-986165 (Drug)
Arm 2: BMS-986165 Dose 2 + Metformin
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) in plasma for metformin with and without BMS-986165
时间窗: Up to 9 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) in plasma for metformin with and without BMS-986165
时间窗: Up to 9 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for metformin with and without BMS-986165
时间窗: Up to 9 days
次要结局
- Incidence of adverse events (AEs)(Up to 13 days)
- Incidence of serious adverse events (SAEs)(Up to 71 days)
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 41 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 vital signs: Heart rate(Up to 41 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval(Up to 41 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS(Up to 41 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval(Up to 41 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF(Up to 41 days)
- Incidence of clinically significant changes in clinical laboratory values: Hematology tests(Up to 41 days)
- Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests(Up to 41 days)
- Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests(Up to 41 days)
研究者
研究点 (1)
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