A Randomized, Double-Blind, Placebo and Active-Controlled, Single-Dose, 4-Treatment Crossover Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 60
- 主要终点
- Change from baseline in QTcF obtained from ECGs extracted from the Holter recordings
研究概览
简要总结
This thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12 possible treatment sequences. Each treatment sequence will comprise all 4 treatments.
详细描述
The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization Phase will have 2 periods: Screening (up to 27 days) and Baseline Period 1 (1 day). Eligibility will be determined during the Screening Period. The Randomization Phase will consist of 8 periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, Treatment Period 3, Baseline Period 4, Treatment Period 4, and a Follow-Up Period. Each Baseline Period will last 1 day, followed by the corresponding treatment period. On the first day of each treatment period, subjects will receive a single dose of the assigned study drug. During each treatment period, subjects will be required to stay in the clinical unit from the baseline period to 24 hours postdose. Subjects will then be released from the clinic and will undergo a washout interval of at least 13 days, during which time they will return for additional PK sampling.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment A
Placebo
干预措施: Placebo (Drug)
Treatment B
E2609 Low dose
干预措施: E2609 (Drug)
Treatment C
E2609 High dose
干预措施: E2609 (Drug)
Treatment D
Moxifloxacin
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Change from baseline in QTcF obtained from ECGs extracted from the Holter recordings
时间窗: Up to 24 hours postdose during each treatment period
Holter recordings are taken from a portable device for continuously monitoring various electrical activity of the cardiovascular system for at least 24 hours. Baseline is defined as the mean of predose QTcF values obtained from ECGs extracted from Holter recordings before dosing during each treatment period.
次要结局
- Change from baseline in ECG recordings: T wave morphology(Predose and then at up to 24 hours postdose in each treatment period)
- Pharmacokinetics of E2609: Cmax(Up to 84 Days)
- Pharmacokinetics of E2609: tmax(Up to 84 Days)
- Change from baseline in ECG recordings: PR interval(Predose and then up to 24 hours postdose in each treatment period)
- Change from baseline in ECG recordings: QRS interval(Predose and then up to 24 hours postdose in each treatment period)
- Change from baseline in ECG recordings: HR(Predose and then up 24 hours postdose in each treatment period)
- Change from baseline in ECG recordings: RR interval(Predose and then at up to 24 hours postdose in each treatment period)
- Pharmacokinetics of E2609: AUC(0-t)(Up to 84 Days)
- Pharmacokinetics of E2609: AUC(0-72h)(Up to 84 Days)
- Pharmacokinetics of E2609: AUC(0-inf)(Up to 84 Days)
- Pharmacokinetics of E2609: t1/2(Up to 84 Days)
- Pharmacokinetics of E2609: CL/F(Up to 84 Days)
- Pharmacokinetics of E2609: Vz/F(Up to 84 Days)