臨床研究等提出・公開システム

Date of registration	July. 05, 2024
Last modified on	Sept. 22, 2025
Trial ID	jRCT2071240028

Scientific Title	Phase 1 Clinical Study of JTV-261 -Single and Multiple Dose Study-
Public Title	Phase 1 Clinical Study of JTV-261 -Single and Multiple Dose Study-

Contact for Scientific Queries	Name	Mitsui Hironori
	Affiliation	Shionogi & Co.,Ltd.
	Address	3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6635-3505
	E-mail	clinicaltrials-info@shionogi.co.jp
Contact for Public Queries	Name	clinical trials information
	Affiliation	Shionogi & Co.,Ltd.
	Address	3-4-1, Nihonbashi-Honcho , Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6635-3505
	E-mail	clinicaltrials-info@shionogi.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 03, 2024
Actual date of first enrollment		Aug. 05, 2024
Target sample size		88
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Healthy Japanese male aged from 20 to 45 years 2. A subject with a body mass index (BMI) of 18.5 to less than 25.0
	Exclusion Criteria	1. A subject who has serious medical history of or complications under treatment for the cerebral, liver, kidneys, heart, lungs, gastrointestinal system, hematological, endocrine system, metabolic system, or psychiatric disorders. 2. A subjcet who has a history of gastrointestinal surgery that could interfere with the absorption of the study drug. 3. A subject who has participated in this study and received the study drug administration. 4. A subject who, in the opinion of the Investigator, has impediments to participation in the study.
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy volunteer
Intervention(s)		Part 1: Administration of a single dose of JTV-261 or placebo in the fasted or fed state. Part 2: Administration of multiple doses of JTV-261 or placebo for 14 days in the fasted state.
Primary Outcome(s)		Safety, Pharmacokinetics

Primary Sponsor	Japan Tobacco Inc.

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka
Telephone	+81-92-283-7701
Approval Status	Approval
Date of approval	Aug. 01, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Sept. 22, 2025	(this page)	Changes
3	April. 22, 2025	Detail	Changes
2	Aug. 26, 2024	Detail	Changes
1	July. 05, 2024	Detail

List of change history