臨床研究等提出・公開システム

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	Japan Tobacco Inc.
	Address	3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
	Telephone	+81-120-404-611
	E-mail	clinicaltrials-info-r@jt.com
Contact for Public Queries	Name	clinical trials information
	Affiliation	Japan Tobacco Inc.
	Address	3-4-1, Nihonbashi-Honcho , Chuo-ku, Tokyo, Japan
	Telephone	+81-120-404-611
	E-mail	clinicaltrials-info-r@jt.com

Recruitment status	Recruiting

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.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety, Pharmacokinetics
Secondary Outcome(s)

Primary Sponsor	Japan Tobacco Inc.

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-shi, Fukuoka
Telephone	+81-92-283-7701
E-Mail
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Aug. 26, 2024	(this page)	Changes
1	July. 05, 2024	Detail

List of change history