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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Placebo; Drug: TS-142; Drug: Zopiclone

• Registration Number: NCT05819710
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-19
• Study Start: 2023-05-15
• Primary Completion: 2023-08-25
• Study Completion: 2023-08-25
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Other protocol defined inclusion criteria could apply.

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.

Other protocol defined exclusion criteria could apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo.
10 mg of TS-142	TS-142	High dose of TS-142
7.5 mg of Zopiclone	Zopiclone	Comparator.
5 mg of TS-142	TS-142	Low dose of TS-142

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan