臨床研究等提出・公開システム

Date of registration	June. 29, 2022
Last modified on	July. 17, 2024
Trial ID	jRCT2071220019

Scientific Title	The Phase I Single Dose Study of OP-2024 in Healthy Male Volunteers
Public Title	OP-2024-002 Study

Contact for Scientific Queries	Name	Taguchi Fumi
	Affiliation	OHARA Pharmaceutical Co.,Ltd.
	Address	36F St.Luke's Tower 8-1, Akashi-cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp
Contact for Public Queries	Name	Department of Clinical Development
	Affiliation	OHARA Pharmaceutical Co.,Ltd.
	Address	36F St.Luke's Tower 8-1, Akashi-cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		July. 06, 2022
Actual date of first enrollment		July. 06, 2022
Target sample size		24
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1) Healthy Japanese male. 2) Those with age >= 18 to <= 40 years. 3) Those with BMI >= 18.5 to < 25.0. 4) Those who have provided voluntary written consent to participate in the study.
	Exclusion Criteria	1) Those with a history of allergies to investigational drug ingredients, drugs, or foods 2) Those who are undergoing treatment for, or have a history of, respiratory, circulatory, central nervous system, gastrointestinal, hepatic, renal, hematopoietic, or endocrine disorders that affect pharmacokinetics 3) Other protocol defined exclusion criteria could apply
	Age Minimum	18age old over
	Age Maximum	40age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Parkinson's disease
Intervention(s)		In each cohort, OP-2024 will be administered orally in single doses of 1, 2, 4, and 6 capsules, respectively.
Primary Outcome(s)		Safety
Secondary Outcome(s)		Pharmacokinetics

Primary Sponsor	OHARA Pharmaceutical Co.,Ltd.

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka, Japan, Fukuoka
Telephone	+81-92-283-7701
Approval Status	Approval
Date of approval	June. 17, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	July. 17, 2024	(this page)	Changes
4	Dec. 04, 2022	Detail	Changes
3	Aug. 26, 2022	Detail	Changes
2	July. 08, 2022	Detail	Changes
1	June. 29, 2022	Detail

List of change history