A Crossover Study to Assess the Effects of FYU-981 on the QT/QTc Interval in Healthy Male and Female Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- QT/QTc Interval
研究概览
简要总结
A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control, in Healthy Male and Female Volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese adult subjects
- •Body mass index: >=18.5 and <27.5
排除标准
- •Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
研究组 & 干预措施
FYU-981 anticipated therapeutic dose
Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral)
干预措施: Moxifloxacin Placebo (Drug)
FYU-981 supratherapeutic dose
Drug: FYU-981, Moxifloxacin Placebo (Oral)
干预措施: FYU-981 (Drug)
FYU-981 supratherapeutic dose
Drug: FYU-981, Moxifloxacin Placebo (Oral)
干预措施: Moxifloxacin Placebo (Drug)
FYU-981 anticipated therapeutic dose
Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral)
干预措施: FYU-981 (Drug)
FYU-981 anticipated therapeutic dose
Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral)
干预措施: Placebo (Drug)
Placebo
Drug: FYU-981 Placebo, Moxifloxacin Placebo (Oral)
干预措施: Placebo (Drug)
Placebo
Drug: FYU-981 Placebo, Moxifloxacin Placebo (Oral)
干预措施: Moxifloxacin Placebo (Drug)
Moxifloxacin
Drug: Moxifloxacin, FYU-981 Placebo (Oral)
干预措施: Placebo (Drug)
Moxifloxacin
Drug: Moxifloxacin, FYU-981 Placebo (Oral)
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
QT/QTc Interval
时间窗: 24 hours
次要结局
未报告次要终点