NCT02153437终止1 期
A Study of the Effects of BMS-919373 on Atrial Effective Refractory Period in Subjects With a Dual-Chamber Pacemaker
Bristol-Myers Squibb5 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2014年10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
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 5
- 主要终点
- The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker
研究概览
简要总结
To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A: BMS-919373
Experimental
BMS-919373 oral Solution/tablet single dose for one day
干预措施: BMS-919373 (Drug)
Arm B: Sotalol
Active Comparator
Sotalol oral Tablet single dose for one day
干预措施: Sotalol (Drug)
Arm C: Placebo for BMS-919373
Placebo Comparator
Oral solution/tablet one single dose for one day
干预措施: Placebo for BMS-919373 (Drug)
结局指标
主要结局
The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker
时间窗: At 0.5, 1, 2, and 4 hours following study drug administration
次要结局
- The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests(At 1, 2, and 4 hours following study drug administration)
- Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline(At 2 hour following study drug administration)
- Safety assessments based on Atrioventricular interval (AVI) and change from baseline(At 1, 2, and 4 hours following study drug administration)
- Safety assessments based on Wenckebach cycle length (WCL) and change from baseline(At 1, 2, and 4 hours following study drug administration)
- Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline(At 1, 2, and 4 hours following study drug administration)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
1 期
Study to Determine the Effect of BMS-791325 on the ECG QTcF Interval in Healthy SubjectsHepatitis CNCT02084953Bristol-Myers Squibb59
终止
2 期
A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial FibrillationParoxysmal Atrial FibrillationNCT02156076Bristol-Myers Squibb158
终止
2 期
Study Evaluating GAP-486 in Heart RhythmArrhythmiaNCT00137293Wyeth is now a wholly owned subsidiary of Pfizer30
终止
早期 1 期
Effect of Timi3 Ultrasound on Myocardial Blow Flow in the Hibernating MyocardiumMyocardial IschemiaNCT00655070University of California, San Francisco9
已完成
2 期
IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)Diabetic CardiomyopathiesHFpEF - Heart Failure With Preserved Ejection FractionType 2 DiabetesNCT04826159Imbria Pharmaceuticals, Inc.49