NCT03541564已完成1 期
A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2018年5月30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
- 84
- 试验地点
- 1
- 主要终点
- Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)
研究概览
简要总结
This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
- •Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening
- •Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.732 m2
排除标准
- •Any medical condition that presents a potential risk and/or may compromise the objectives of the study, including a history or presence of active liver disease
- •A personal history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
- •History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986165 Dose 1 oral administration
Experimental
BMS-986165 therapeutic single dose
干预措施: BMS-986165 (Drug)
BMS-986165 Dose 2 oral administration
Experimental
BMS-986165 supratherapeutic single dose
干预措施: BMS-986165 (Drug)
Moxifloxacin Dose 3 oral administration
Active Comparator
Moxifloxacin positive control single dose
干预措施: Moxifloxacin (Drug)
Placebo Dose 4 oral administration
Placebo Comparator
Placebo single dose
干预措施: Placebo (Other)
结局指标
主要结局
Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)
时间窗: From baseline to 5 days
次要结局
- Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG(From baseline to 5 days)
- Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations(Up to 28 days)
- Heart rate (HR) as determined by 12-lead ECG(5 days)
- Maximum observed concentration (Cmax) as determined by plasma concentration(5 days)
- Time of maximum observed concentration (Tmax) as determined by plasma concentration(5 days)
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] as determined by plasma concentration(5 days)
- PR as determined by 12-lead ECG(5 days)
- Incidence of serious adverse events (SAE)(Up to 28 days)
- Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG(From baseline to 5 days)
- QRS as determined by 12-lead ECG(5 days)
- Incidence of adverse events (AE)(Up to 28 days)
- Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration(5 days)
研究者
研究点 (1)
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