臨床研究等提出・公開システム

Japanese

Date of registration	June. 11, 2025
Last modified on	June. 11, 2025
Trial ID	jRCT2031250158

Scientific Title	Drug-drug interaction study of OP-2024 with Proton pump inhibitor (Rabeprazole Sodium) or Magnesium Oxide in Healthy Male Volunteers
Public Title	OP-2024-007 Study

Contact for Scientific Queries	Name	Hashimoto Hideaki
	Affiliation	OHARA Pharmaceuitical Co., Ltd
	Address	36F St. Luke's Tower 8-1, Akachi-cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp
Contact for Public Queries	Name	Hashimoto Hideaki
	Affiliation	OHARA Pharmaceuitical Co., Ltd
	Address	36F St. Luke's Tower 8-1, Akachi-cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		June. 18, 2025
Actual date of first enrollment
Target sample size		20
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) BMI at time of screening is >= 18.5 to < 25.0. 3) Written informed consent to participate in this trial can be obtained.
	Exclusion Criteria	1) History of allergies to any component of the investigational product, drug, or food. 2) Subjects with or at risk for angle-closure glaucoma. 3) Subjects with pheochromocytoma or paraganglioma, or other catecholamine-secreting tumors. 4) History of neuroleptic malignant syndrome or nontraumatic rhabdomyolysis. 5) History of diseases affecting the gastrointestinal tract, liver, kidneys, or heart that may influence the absorption, distribution, metabolism, or excretion of drugs. 6) History of major surgery involving the gastrointestinal tract, including gastrectomy, gastrostomy, or bowel resection (excluding appendectomy).
	Age Minimum	18age old over
	Age Maximum	40age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Parkinson's disease
Intervention(s)		OP-2024 will be administered as a single oral dose, alone and in combination with magnesium oxide or rabeprazole.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Pharmacokinetics
Secondary Outcome(s)		Safety

Primary Sponsor	OHARA Pharmaceuitical Co., Ltd

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board
Address	3F Yotsuya Medical Bldg, 20 Samon-cho, Shinjuku-ku, Tokyo, Japan, Tokyo
Telephone
E-Mail
Approval Status	Approval
Date of approval	May. 27, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none