臨床研究等提出・公開システム

Date of registration	Nov. 05, 2023
Last modified on	Jan. 17, 2025
Trial ID	jRCT2031230432

Scientific Title	The phase I mass balance study to investigate the pharmacokinetics of OP-724 following a single dose of 14C-labeled OP-724 in healthy male volunteers.
Public Title	OP-724-001 study

Contact for Scientific Queries	Name	Yuushi Haruyama
	Affiliation	Ohara pharmaceutical Co., Ltd.
	Address	8-1 Akashi-tyo, Chuo-ku, Tokyo
	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	8-1 Akashi-tyo, Chuo-ku, Tokyo
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 10, 2023
Actual date of first enrollment		Nov. 10, 2023
Target sample size		6
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 subjects. 2: Age at the time of obtaining written informed consent is >=18 to <45 years old. 3: Subjects who are capable of fully understanding the clinical trial and providing written informed consent.
	Exclusion Criteria	1: Subjects with any clinilcal abnormality assessed by the investigator or subinvestigator in laboratory tests, vital signs, or 12-lead ECG in eligibility testing. 2: Subjects with a QTcF of > 450 msec on a 12-lead ECG in the eligibility test. 3: Subjects who weighs < 50.0 kg in the eligibility test.
	Age Minimum	18age old over
	Age Maximum	45age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy volunteers
Intervention(s)		[14C]OP-724 will be administered intravenous for 4 hours continuously.
Primary Outcome(s)		Pharmacokinetics
Secondary Outcome(s)		Satety

Primary Sponsor	OHARA Pharmaceutical Co.,Ltd.

Source of Monetary Support / Secondary Sponsor	AMED(Japan Agency for Medical Research and Development)

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board, P-One Clinic, Keikokai Medical Corporation
Address	View Tower Hachioji 4F, 8-1, Yokamachi, Hachioji, Tokyo, Tokyo
Telephone	+81-42-625-5216
E-Mail	irbjimukyoku@keikokai-gr.or.jp
Approval Status	Approval
Date of approval	Oct. 06, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Jan. 17, 2025	(this page)	Changes
3	July. 12, 2024	Detail	Changes
2	Nov. 21, 2023	Detail	Changes
1	Nov. 05, 2023	Detail

List of change history