臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 17, 2022
Last modified on	Oct. 18, 2022
Trial ID	jRCT2071210134

Scientific Title	A Clinical trial for Resminostat in Healthy Volunteers to Investigate the Effect of Food
Public Title	A Clinical trial for Resminostat to Investigate the Effect of Food

Contact for Scientific Queries	Name	Asami Tsubasa
	Affiliation	Yakult Honsha Co., Ltd.
	Address	1-10-30, Kaigan, Minato-ku, Tokyo
	Telephone	+81-3-6625-8913
	E-mail	clinical_development@yakult.co.jp
Contact for Public Queries	Name	Clinical Development
	Affiliation	Yakult Honsha Co., Ltd.
	Address	1-10-30, Kaigan, Minato-ku, Tokyo
	Telephone	+81-3-6625-8913
	E-mail	clinical_development@yakult.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 01, 2022
Actual date of first enrollment		April. 03, 2022
Target sample size		12
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	crossover assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	-Caucasian males aged between 20 (inclusive) and 45 years of age (inclusive) at the time informed consent is obtained. -Body Mass Index between 18.5 kg/m2 (inclusive) and 30.0 kg/m2 (inclusive) at the time informed consent is obtained. -Written informed consent obtained from the subject.
	Exclusion Criteria	-Clinical significant medical history or concomitant disease of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder. -History of surgery, such as gastrectomy, gastrointenstinal suture, or intenstinal resection that would potentially alter absorption of drugs. However, the history of appendicectomy is acceptable. -History of clinically significant hypersensitivity or allergy to any drugs or foods.
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Cutaneous T cell lymphoma
Intervention(s)		Using the crossover method of 2 groups x 2 periods, Resminostat is orally administered under fasted and fed conditions in an open-label manner.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		PK: Pharmacokinetic parameters
Secondary Outcome(s)		Safety: Type, frequency, and severity of adverse events and adverse drug reactions

Primary Sponsor	Yakult Honsha 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, Fukuoka
Telephone	+81-92-283-7701
E-Mail
Approval Status	Approval
Date of approval	Feb. 25, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Oct. 18, 2022	(this page)	Changes
2	June. 18, 2022	Detail	Changes
1	Mar. 17, 2022	Detail

List of change history