NCT00979316已完成1 期
Randomized, Double-Blinded, Placebo-Controlled, Open Label Positive- Controlled, Four-Way Crossover Study of the Electrocardiographic Effects of BMS-708163 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2009年9月最近更新:
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
- 62
- 试验地点
- 1
- 主要终点
- Effect on the electrocardiographic QT interval corrected for heart rate (QTc) in healthy subjects
研究概览
简要总结
The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Body Mass Index (BMI) of 18 to 32 kg/m², inclusive.
- •Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
- •Healthy subjects
排除标准
- •History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
- •Sexually active fertile men not using effective birth control (double barrier) if their partners are WOCBP
- •Women who are pregnant or breastfeeding
- •History of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
- •History of hypokalemia, history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- •Any clinically significant ECG abnormality
- •History of seizure disorders
- •History of drowning survival
研究组 & 干预措施
BMS-708163 (800 mg)
Experimental
干预措施: BMS-708163 (Drug)
BMS-708163 (200 mg)
Experimental
干预措施: BMS-708163 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Moxifloxacin
Active Comparator
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Effect on the electrocardiographic QT interval corrected for heart rate (QTc) in healthy subjects
时间窗: Serial triplicate ECGs at -60, -40 and -20 minutes prior to dosing: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period
次要结局
- To assess the effects of BMS-708163 on other ECG endpoints (heart rate [HR], QRS and PR intervals), and changes in waveform morphology(At -60, -40 and -20 minutes prior to dosing; at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period)
研究者
研究点 (1)
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