A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: TS-142
* Drug: TS-142
* Drug: Zopiclone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 mg of TS-142<br>Low dose of TS-142 | Drug: TS-142<br>* Single dose of 5 mg of TS-142<br>|
| Experimental: 10 mg of TS-142<br>High dose of TS-142 | Drug: TS-142<br>* Single-dose of 10 mg of TS-142<br>|
| Experimental: 7.5 mg of Zopiclone<br>Comparator. | Drug: Zopiclone<br>* Single-dose of 7.5 mg of zopiclone<br>|
| Experimental: Placebo<br>Placebo. | Drug: Placebo<br>* Single-dose of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RMS of COP in eye-open condition | 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 | 8 hour postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RMS of COP in eye-closed condition | 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-closed condition | 8 hour postdose | 
| Trajectory of COP in eye-open condition | the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-open condition | 8 hour postdose | 
| Trajectory of COP in eye-closed condition | the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-closed condition | 8 hour postdose |