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Completed

NCT Number: NCT05819710

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

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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Key information

Conditions

Healthy Subjects

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TS-142

Drug

Single dose of 5 mg of TS-142

Zopiclone

Drug

Single-dose of 7.5 mg of zopiclone

Placebo

Drug

Single-dose of placebo

Primary outcomes

  1. RMS of COP in eye-open condition

    Time frame: 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 outcomes

  1. RMS of COP in eye-closed condition

    Time frame: 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

  2. Trajectory of COP in eye-open condition

    Time frame: 8 hour postdose

    the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-open condition

  3. Trajectory of COP in eye-closed condition

    Time frame: 8 hour postdose

    the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-closed condition

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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