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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05819710
• Other study ID #: TS142-305
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2023
• Est. completion date: August 25, 2023

Study information

• Verified date: April 2023
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• TS-142
Single dose of 5 mg of TS-142
• TS-142
Single-dose of 10 mg of TS-142
• Zopiclone
Single-dose of 7.5 mg of zopiclone
• Placebo
Single-dose of placebo

Locations

Country	Name	City	State
Japan	Taisho Pharmaceutical Co., Ltd selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	RMS of COP in eye-closed 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-closed condition	8 hour postdose
Secondary	Trajectory of COP in eye-open condition	the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-open condition	8 hour postdose
Secondary	Trajectory of COP in eye-closed condition	the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-closed condition	8 hour postdose