A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 5 mg of TS-142 Low dose of TS-142 |
Drug: TS-142
Single dose of 5 mg of TS-142
|
| Experimental: 10 mg of TS-142 High dose of TS-142 |
Drug: TS-142
Single-dose of 10 mg of TS-142
|
| Experimental: 7.5 mg of Zopiclone Comparator. |
Drug: Zopiclone
Single-dose of 7.5 mg of zopiclone
|
| Experimental: Placebo Placebo. |
Drug: Placebo
Single-dose of placebo
|
Outcome Measures
Primary Outcome Measures
- RMS of COP in eye-open condition [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
Secondary Outcome Measures
- RMS of COP in eye-closed condition [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-closed condition
- Trajectory of COP in eye-open condition [8 hour postdose]
the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-open condition
- Trajectory of COP in eye-closed condition [8 hour postdose]
the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-closed condition
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taisho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
Sponsors and Collaborators
- Taisho Pharmaceutical Co., Ltd.
Investigators
- Study Director: Taisho Director, Taisho Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TS142-305