NCT00850746已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo- and Active- Controlled, Crossover Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Male and Female Adult 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
- 入组人数
- 80
- 主要终点
- Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo
研究概览
简要总结
This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy adults.
详细描述
Each subject participates in all four treatment periods separated by washout periods.
In order to maintain the blind between arms, all subjects will receive the same number of tablets per day in each period of either active drug or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Male or non pregnant, non lactating female
- •Weighing at least 45 kg
- •Body Mass Index (BMI) between 18 and 32 kg/m2
排除标准
- •The subject has evidence of any cardiac conduction abnormalities
- •The subject has a previous history of any medical or psychiatric condition that would preclude participation in the study
- •The subject has participated in another clinical trial in the last 30 days
- •The subject anticipates an inability to abstain from alcohol, or caffeine use, or from grapefruit and grapefruit juice from 48 hours prior to the administration of the first dose of YM443 on Day 1 of Period 1 and throughout the duration of the study
- •The subject has used tobacco-containing products and nicotine or nicotine-containing products within six months prior to Screening
- •The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week or has a history of substance abuse, drug addiction, or alcoholism within 2 years prior to Screening
- •The subject has donated any whole blood or cellular blood component or has undergone significant loss of blood or has received transfusion of any blood or blood products within 56 days of Day -1 of Period 1 or has donated plasma within 7 days of Day -1 of Period 1
研究组 & 干预措施
A. Placebo
Placebo Comparator
干预措施: Placebo (Drug)
B. Ym443 Lower Dose
Experimental
干预措施: YM443 (Drug)
C. YM443 Higher Dose
Experimental
干预措施: YM443 (Drug)
D. Moxiflocxacin
Active Comparator
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo
时间窗: Following four days of dosing
次要结局
- The mean change of the QTcI (Individual correction) and QTcB (Bazett's correction) between each active treatment and placebo.(Following four days of dosing)
- The pharmacokinetics of YM443 in these subjects(Day 5)
- The safety and tolerability of YM443(Following four days of dosing)
研究者
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