臨床研究等提出・公開システム

Date of registration	June. 27, 2023
Last modified on	July. 17, 2024
Trial ID	jRCT2071230034

Scientific Title	Food effect study of OP-2024 in healthy male adults
Public Title	OP-2024-005 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. 14, 2023
Actual date of first enrollment		July. 14, 2023
Target sample size		24
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	crossover assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1) Healthy Japanese male. 2) Age at the time of obtaining written informed consent is >= 18 to <= 40 years old. 3) BMI at time of screening is >= 18.5 to < 25.0. 4) Written informed consent to participate in this trial can be obtained.
	Exclusion Criteria	1) History of allergy to investigational drug ingredients, drugs, or foods. 2) History of or undergoing treatment for any diseases of respiratory, circulatory, central nervous system, gastrointestinal, hepatic, renal, hematological, or endocrine disorders that affect pharmacokinetics. 3) Other protocol defined exclusion criteria could be applied.
	Age Minimum	18age old over
	Age Maximum	40age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Parkinson's disease
Intervention(s)		A single oral dose of 3 capsules of OP-2024 will be administered under any one meal condition (fasting, after meal or before meal) on Day 1 of each 3-day period in Periods 1, 2, and 3.
Primary Outcome(s)		Pharmacokinetics
Secondary Outcome(s)		Safety

Primary Sponsor	OHARA Pharmaceutical Co.,Ltd.

Secondary Sponsor

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka 812-0025, Japan, Fukuoka
Telephone	+81-92-283-7701
Approval Status	Approval
Date of approval	June. 23, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	July. 17, 2024	(this page)	Changes
3	Nov. 03, 2023	Detail	Changes
2	Aug. 04, 2023	Detail	Changes
1	June. 27, 2023	Detail

List of change history