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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2023-08-25

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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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5 mg of TS-142

Low dose of TS-142

Group Type EXPERIMENTAL

TS-142

Intervention Type DRUG

Single dose of 5 mg of TS-142

10 mg of TS-142

High dose of TS-142

Group Type EXPERIMENTAL

TS-142

Intervention Type DRUG

Single-dose of 10 mg of TS-142

7.5 mg of Zopiclone

Comparator.

Group Type EXPERIMENTAL

Zopiclone

Intervention Type DRUG

Single-dose of 7.5 mg of zopiclone

Placebo

Placebo.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Single-dose of placebo

Interventions

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TS-142

Single dose of 5 mg of TS-142

Intervention Type DRUG

TS-142

Single-dose of 10 mg of TS-142

Intervention Type DRUG

Zopiclone

Single-dose of 7.5 mg of zopiclone

Intervention Type DRUG

Placebo

Single-dose of placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects who are Japanese male or female aged 65 years or older at the time of obtaining informed consent
2. 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
3. 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.

Exclusion Criteria

1. Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
2. 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
3. Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes