A Thorough Corrected QT Interval Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- QTcI (QT interval corrected) duration
研究概览
简要总结
The purpose of this study is to determine the effects of K-877 on ECG parameters with a focus on cardiac repolarization compared with placebo in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subject provides written informed consent before any study specific evaluation is performed.
- •Subject is a healthy adult male or female volunteer, of any race and ethnicity, between the ages of 18 and 45 years, inclusive.
- •Subject has a body mass index of 18 to 30 kg/m2, inclusive.
排除标准
- •Subject has clinically relevant abnormalities in the screening or check in assessments.
- •Subject has a supine blood pressure after resting for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic.
- •Subject has a supine Heart Rate (HR) (as measured at Screening or Check-in during collection of vital signs) after resting for at least 5 minutes that is outside the range of 40 to 90 beats per minute.
研究组 & 干预措施
Sequence D
Sequence D
干预措施: Placebo (Other)
Sequence A
Sequence A
干预措施: K-877 Low Dose (Drug)
Sequence A
Sequence A
干预措施: Moxifloxacin (Drug)
Sequence A
Sequence A
干预措施: Placebo (Other)
Sequence D
Sequence D
干预措施: K-877 High Dose (Drug)
Sequence A
Sequence A
干预措施: K-877 High Dose (Drug)
Sequence B
Sequence B
干预措施: K-877 Low Dose (Drug)
Sequence B
Sequence B
干预措施: Moxifloxacin (Drug)
Sequence B
Sequence B
干预措施: Placebo (Other)
Sequence B
Sequence B
干预措施: K-877 High Dose (Drug)
Sequence C
Sequence C
干预措施: K-877 Low Dose (Drug)
Sequence C
Sequence C
干预措施: Moxifloxacin (Drug)
Sequence C
Sequence C
干预措施: Placebo (Other)
Sequence C
Sequence C
干预措施: K-877 High Dose (Drug)
Sequence D
Sequence D
干预措施: K-877 Low Dose (Drug)
Sequence D
Sequence D
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
QTcI (QT interval corrected) duration
时间窗: 24 hrs
次要结局
未报告次要终点