NCT05819710已完成1 期
A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly 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
- 43
- 试验地点
- 1
- 主要终点
- RMS of COP in eye-open condition
研究概览
简要总结
This is a study to investigate the next-day residual effects of a single bedtime dosing of 5 mg and 10 mg of TS-142 in Japanese healthy elderly participants in double-blind manner.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are Japanese male or female aged 65 years or older at the time of obtaining informed consent
- •Subjects with a body Mass Index (BMI) from 18.5 to less than 25.0 and a body weight of 40.0 kg or over at the screening test
- •Subjects who are judged by the principal investigators or subinvestigators as an eligible for the clinical trial participation based on the results of tests conducted in the screening, VISIT 1 and prior to the administration of the investigational drug.
- •Other protocol defined inclusion criteria could apply.
排除标准
- •Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
- •Subjects who have any unsuitable medical histories for participation in this clinical trial, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
- •Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts.
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
10 mg of TS-142
Experimental
High dose of TS-142
干预措施: TS-142 (Drug)
7.5 mg of Zopiclone
Experimental
Comparator.
干预措施: Zopiclone (Drug)
Placebo
Experimental
Placebo.
干预措施: Placebo (Drug)
5 mg of TS-142
Experimental
Low dose of TS-142
干预措施: TS-142 (Drug)
结局指标
主要结局
RMS of COP in eye-open condition
时间窗: 8 hour postdose
the area of the circle whose radius is the root mean square (RMS) value of center of pressure (COP) calculated by the stabilometer in eye-open condition
次要结局
- RMS of COP in eye-closed condition(8 hour postdose)
- Trajectory of COP in eye-open condition(8 hour postdose)
- Trajectory of COP in eye-closed condition(8 hour postdose)
研究者
研究点 (1)
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