NCT02241759已完成1 期
A Phase I, Single-Centre, Randomised, Placebo and Positive- Controlled, Parallel-Group Study of the Electrocardiographic Effects of TA-8995 in Healthy Male and Female Subjects
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
- Xention Ltd
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo
研究概览
简要总结
A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Healthy male or females of non-child bearing potential
排除标准
- •Receiving any other drug therapy
- •Clinically significant medical history
- •Abnormal ECGs or vital signs
研究组 & 干预措施
TA-8995
Experimental
Single oral dose of 150mg TA-8995
干预措施: TA-8995 (Drug)
Placebo
Experimental
Single oral dose of placebo to TA-8995
干预措施: Placebo (Drug)
Moxifloxacin
Active Comparator
Single open-label oral dose of 400mg moxifloxacin
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo
时间窗: 4 days
次要结局
- Relationship between plasma levels of TA-8995 and the QTcF effect(4 days)
研究者
研究点 (1)
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