臨床研究等提出・公開システム

Scientific Title	SJP-0008 Phase I -QT/QTc evaluation Study in Healthy Japanese Adult Male Subjects-
Public Title	QT/QTc evaluation Study in Healthy Japanese Adult Male Subjects

Contact for Scientific Queries	Name	Ohtori Akira
	Affiliation	Senju Pharmaceutical Co., Ltd.
	Address	6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-777-1020
	E-mail	clinical-trial-slos@senju.co.jp
Contact for Public Queries	Name	Senju Laboratory of Ocular Sciences
	Affiliation	Senju Pharmaceutical Co., Ltd.
	Address	6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-777-1020
	E-mail	clinical-trial-slos@senju.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Sept. 06, 2021
Actual date of first enrollment		Sept. 06, 2021
Target sample size		48
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Healthy Japanese male - 20-39 years of age at the time of the informed consent - Other protocol-specified inclusion criteria may apply
	Exclusion Criteria	- History or complications of diseases such as the heart, kidneys, liver, and brain that are considered inappropriate for participation in this clinical trial - History or complications of serious drug allergies or food allergies -Judged by the investigator, etc. to be ineligible for this clinical trial -Other protocol-specified exclusion criteria may apply
	Age Minimum	20age old over
	Age Maximum	40age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Central Retinal Artery Occlusion
Intervention(s)		Administration of SJP-0008, placebo and Moxifloxacin and blood collection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Prolongation of QT/QTc interval
Secondary Outcome(s)

Primary Sponsor	Senju Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	The IRB of Kitasato University Shirokane Campus
Address	5-9-1, Shirogane, Minato-ku, Tokyo
Telephone	+81-3-5791-6177
E-Mail	irb-pt@insti.kitasato-u.ac.jp
Approval Status	Approval
Date of approval	July. 28, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history