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

NCT05819710 | Completed Phase 1

• 1 other identifier: TS142-305
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (4)

5 mg of TS-142

EXPERIMENTAL

Low dose of TS-142

Drug: TS-142

10 mg of TS-142

EXPERIMENTAL

High dose of TS-142

Drug: TS-142

7.5 mg of Zopiclone

EXPERIMENTAL

Comparator.

Drug: Zopiclone

Placebo

EXPERIMENTAL

Placebo.

Drug: Placebo

Interventions

TS-142 DRUG

Single dose of 5 mg of TS-142

5 mg of TS-142

Zopiclone DRUG

Single-dose of 7.5 mg of zopiclone

7.5 mg of Zopiclone

Placebo DRUG

Single-dose of placebo

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

TS-142; zopiclone

Study Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: May 15, 2023
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: February 28, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)