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

JRCT ID: jRCT2071230009

Registered date:17/04/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Insomnia
• Date of first enrollment: 15/05/2023
• Target sample size: 16
• Study type: Interventional
• Intervention(s): single oral dose of 5 mg, 10 mg of TS-142 (INN: vornorexant), 7.5 mg of zopiclone, and placebo

Outcome(s)

• Primary Outcome: RMS of COP: 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

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 Information

• Primary Sponsor: Mita Seiji
• Secondary ID(s): NCT05819710