NCT01461460已完成1 期
A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年11月28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
- 48
- 试验地点
- 1
- 主要终点
- QTcF Change from Baseline
研究概览
简要总结
The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
详细描述
To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701 free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's formula (QTcF) in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects between 18 and 45 years of age, inclusive.
- •Healthy males and females with no clinically significant abnormalities.
- •Body mass index ≥18.0 kg/m2 and ≤30.0 kg/m2
排除标准
- •Sustained supine systolic blood pressure >140 or <100 mmHg or a diastolic blood pressure >90 or <60 mmHg at the Screening and Day 1 Visit.
- •Abnormal ECG at Screening or Day -1 Visits indicating a second or third-degree atrioventricular block, or QRS >110 msec, QTcF >450 msec for males and >470 msec for females, PR interval >200 msec, or any rhythm other than sinus rhythm which is interpreted by the Investigator as clinically significant - History of unexplained infections or current signs of infection
- •History of risk factors for Torsades de Pointes, including unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, hypomagnesemia, or family history of Long QT Syndrome or Brugada Syndrome
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
TR-701 FA 200 mg plus Placebo
Experimental
干预措施: TR-701 FA 200 mg plus Placebo (Drug)
TR-701 FA 1200 mg
Experimental
干预措施: TR-701 FA 1200 mg (Drug)
Moxifloxacin 400 mg
Active Comparator
干预措施: Moxifloxacin 400 mg (Drug)
结局指标
主要结局
QTcF Change from Baseline
时间窗: 24 Hours
Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).
次要结局
未报告次要终点
研究者
研究点 (1)
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