NCT07422298已完成1 期
A Phase 1, Randomized, Double-blind, Positive-controlled, Placebo-controlled, 4-Period Crossover, Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986278 on Cardiac Repolarization in Healthy Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)
研究概览
简要总结
The purpose of this study is to evaluate the effect of BMS-986278 on the cardiac repolarization 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Female individuals not of childbearing potential and males.
- •Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
- •18 to 55 years of age, inclusive, at the time of signing the informed consent with a BMI 18.0 to 32.0 kg/m2, inclusive.
- •Other protocol-defined Inclusion/
排除标准
- 未提供
研究组 & 干预措施
Treatment D
Experimental
干预措施: Moxifloxacin (Drug)
Treatment B
Experimental
干预措施: BMS-986278 (Drug)
Treatment C
Placebo Comparator
干预措施: Placebo (Drug)
Treatment B
Experimental
干预措施: Placebo (Drug)
Treatment D
Experimental
干预措施: Placebo (Drug)
Treatment A
Experimental
干预措施: BMS-986278 (Drug)
结局指标
主要结局
Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)
时间窗: Up to Day 13
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
时间窗: Up to Day 13
次要结局
- Change from baseline heart rate (HR)(Up to Day 13)
- Placebo-corrected change from baseline HR(Up to Day 13)
- Change from baseline PR interval(Up to Day 13)
- Placebo-corrected change from baseline PR interval(Up to Day 13)
- Change from baseline QRS interval(Up to Day 13)
- Placebo-corrected change from baseline QRS interval(Up to Day 13)
- Number of participants with categorical outliers for QTcF(Up to Day 13)
- Number of participants with categorical outliers for HR(Up to Day 13)
- Number of participants with categorical outliers for PR interval(Up to Day 13)
- Number of participants with categorical outliers for QRS interval(Up to Day 13)
- Number of participants with treatment-emergent changes of electrocardiogram (ECG) morphology(Up to Day 13)
- Change from baseline QTcF (ΔQTcF)(Up to Day 13)
- Placebo-corrected change from baseline QTcF (ΔΔQTcF)(Up to Day 13)
- Number of participants with non-serious adverse events (AEs)(Up to approximately 17 weeks)
- Number of participants with Serious AEs (SAEs)(Up to approximately 17 weeks)
- Number of participants with AEs leading to study intervention discontinuation(Up to approximately 17 weeks)
- Number of participants with vital sign abnormalities(Up to approximately 17 weeks)
- Number of participants with clinical laboratory assessment abnormalities(Up to approximately 17 weeks)
- Number of participants with 12-lead ECG abnormalities(Up to approximately 17 weeks)
- Number of participants with physical examination abnormalities(Up to approximately 17 weeks)
- Maximum observed concentration (Cmax)(Up to Day 13)
- Time of maximum observed concentration (Tmax)(Up to Day 13)
- Area under the concentration-time curve in 1 dosing interval (AUC[TAU])(Up to Day 13)
研究者
研究点 (2)
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