臨床研究等提出・公開システム

Scientific Title	Pharmacokinetic study of STN1012600 ophthalmic solution in healthy adult males volunteers
Public Title	Pharmacokinetic study of STN1012600 ophthalmic solution in healthy adult males volunteers

Contact for Scientific Queries	Name	Koji Oka
	Affiliation	Santen pharmaceutical co.,ltd
	Address	4-20 Ofuka-cho, Kita-ku, Osaka, Japan
	Telephone	+81-6-4802-9341
	E-mail	clinical@santen.co.jp
Contact for Public Queries	Name	Koji Oka
	Affiliation	Santen pharmaceutical co.,ltd
	Address	4-20 Ofuka-cho, Kita-ku, Osaka, Japan
	Telephone	+81-6-4802-9341
	E-mail	clinical@santen.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 25, 2023
Actual date of first enrollment		June. 11, 2023
Target sample size		8
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects who can comply with scheduled visits and the examination and observation as specified in the clinical study protocol
	Exclusion Criteria	1)Subjects have a disease and/or abnormal laboratory value which is considered inappropriate from safety evaluation perspective 2)Subjects who are inappropriate as participants in this study in the opinion of the investigator or sub investigator
	Age Minimum	18age old over
	Age Maximum	35age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		open angle glaucoma (OAG) or ocular hypertension (OHT)
Intervention(s)		STN1012600 ophthalmic solution 0.002%, 1 drop once daily for 7 days
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Plasma pharmacokinetics
Secondary Outcome(s)

Primary Sponsor	Santen pharmaceutical co.,ltd

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29 Miyahara Yodogawa-ku, Osaka-shi, Osaka, Japan 532-0003, Osaka
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	April. 21, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history