臨床研究等提出・公開システム

Japanese

Date of registration	April. 17, 2023
Last modified on	Feb. 27, 2025
Trial ID	jRCT2071230009

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

Contact for Scientific Queries	Name	Mita Seiji
	Affiliation	Taisho Pharmaceutical Co., LTD.
	Address	3-24,1, Takada, Toshima-Ku, Tokyo
	Telephone	+81-3-3985-1118
	E-mail	shu_chiken@taisho.co.jp
Contact for Public Queries	Name	Development Headquarters Development Management
	Affiliation	Taisho Pharmaceutical Co., LTD.
	Address	3-24,1, Takada, Toshima-Ku, Tokyo
	Telephone	+81-3-3985-1118
	E-mail	shu_chiken@taisho.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 12, 2023
Actual date of first enrollment		May. 15, 2023
Target sample size		16
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	crossover assignment
	purpose	other
Key inclusion & exclusion criteria	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.
	Age Minimum	65age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Insomnia
Intervention(s)		single oral dose of 5 mg, 10 mg of TS-142 (INN: vornorexant), 7.5 mg of zopiclone, and placebo
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		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
Secondary Outcome(s)

Primary Sponsor	Taisho Pharmaceutical Co., LTD.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka, 812-0025, Japan, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	May. 11, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT05819710
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Feb. 27, 2025	(this page)	Changes
4	Nov. 05, 2023	Detail	Changes
3	Sept. 05, 2023	Detail	Changes
2	June. 07, 2023	Detail	Changes
1	April. 17, 2023	Detail

List of change history