A Clinical Pharmacology Study of NPC-15 to Evaluate Arrhythmogenic Effect in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Time matched, baseline-adjusted change in Fridericia-corrected QTc (QTcF) intervals
研究概览
简要总结
A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)
详细描述
This study is a single center, open label, dose escalation trial to evaluate prolongation effect on QT interval of NPC-15 (melatonin 8mg or 16mg).
The trial compose of 3 periods; During the each period, eligible volunteers wll be administered placebo, NPC-15 4g (melatonin 8mg) and NPC-15 8g(melatonin 16mg) as a sequential manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study is a single-arm, open label, dose escalation study. QT interval will be evaluated by blinding outcome assessor in this study.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with BMI ≥ 17.6 kg/m2 and < 30.0 kg/m
- •Subject who falls asleep at between 21:00 and 25:00 and wakes up at between 5:00 and 9:00 during 1 week prior to the first study drug administration.
- •Subject who is able to comply with the study requirements during the study period.
排除标准
- •Subject with QTcF interval greater than 450 ms in male or greater than 470 ms in female on the 12-lead electrocardiogram (ECG), or with clinically significant ECG abnormalities in other findings.
- •Subject who has a family history of Torsades de Pointes (TdP) or long QT syndrome.
- •Subject who has a history of hypersensitivity or allergies to melatonin or ramelteon.
- •Subject who has a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments.
- •Subject who received any non-prescription or prescription drug within 2 weeks prior to the first study drug administration.
- •Subject who received any product containing St Jones Wart or any supplement containing melatonin within 4 weeks prior to the first study drug administration.
- •Subject who has a history of smoking habit or was possibly exposed to passive smoking on a daily basis within 24 weeks prior to the first study drug administration.
- •Subject who, in the opinion of the investigator or sub-investigator, is unsuitable to be involved in the study.
研究组 & 干预措施
study drug
Study drug (NPC-15 and/or Placebo ) will be orally administered once with 200 ml of water at 20:00 on the first days of Period I, Period II and Period III.
干预措施: NPC-15 and/or Placebo (Drug)
结局指标
主要结局
Time matched, baseline-adjusted change in Fridericia-corrected QTc (QTcF) intervals
时间窗: Day1 and Day2 of each periods (3 periods)
QTcF interval is a common endpoints to evaluate arrhythmogenic effect of test drug
次要结局
- Serum melatonin concentration(Up to 12 hours post dose in each period (3 periods))
- Maximum drug concentration time (Tmax) of melatonin(Up to 12 hours post dose in each period (3 periods))
- Area under the blood concentration time curve (AUC) of melatonin(Up to 12 hours postdose in each period (3 periods))
- Maximum drug concentration (Cmax) of melatonin(Up to 12 hours post dose in each period (3 periods))
- Terminal elimination rate constant (λz) of melatonin(Up to 12 hours post dose in each period (3 periods))
- Mean residence time (MRT) of melatonin(Up to 12 hours postdose in each period (3 periods))
- Elimination half-life (t1/2) of melatonin(Up to 12 hours post dose in each period)
- Clearance (CL) of melatonin(Up to 12 hours post dose in each period (3 periods))
- Volume of distribution (Vd) of melatonin(Up to 12 hours postdose in each period (3 periods))
- Adverse Events(Up to 36 hours post dose of Period III)