ACTRN12610000292077已完成1 期
A Randomized, Double-blind, Placebo- and Positive-controlled, Parallel Study to Evaluate the Effect of SYR-472 on the QT/QTc Interval in Healthy Adult Male and Female Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •*Subjects must be healthy volunteers
- •*Subjects must weigh at least 50 kg and have a body mass index greater than or equal to 18.5 kg/m2 and less than 30 kg/m2
- •*Subjects must be in good health in the judgment of the investigator.
排除标准
- •* Subjects will not be enrolled if the screening electrocardiogram has abnormalities including second- or third-degree atrioventricular block, or one or more of the following: QTcF >450 milliseconds (ms), QRS >120 ms, PR interval of >240 ms or any other rhythm than sinus rhythm, which is interpreted by the investigator to be clinically significant.
- •* History of additional risk factors for Torsade de pointes (e.g., long QT syndrome)
- •* Has a heart rate at rest of <50 bpm or >100 bpm
- •*Uses prescription medications within 4 weeks (28 days) prior to the start of the investigational drug administration
- •*Use of over-the-counter medications within 1 week (7 days) prior to the start of the investigational drug administration.
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