臨床研究等提出・公開システム

Date of registration	Oct. 01, 2018
Last modified on	Sept. 10, 2019
Trial ID	jRCT2080224071

Scientific Title	K-755 Phase 1 study
Public Title	K-755 Phase 1 study

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Kowa Company, Ltd.
	Address
	Phone Number
	E-mail Address	ctrdinfo@kowa.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Kowa Company, Ltd.
	Address
	Phone Number
	E-mail Address	ctrdinfo@kowa.co.jp

Recruitment Status	completed

Date of First Enrolment		Sept. 24, 2018
Target Sample Size		78
Study Type		Interventional
Study Design	Study Design	DBT
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	healthy males
	Exclusion Criteria	subjects who having a history of drug allergy
	Minimum Age	20age old over
	Maximum Age	35age old under
	Gender	Male
Health Condition or Problem Studied		healthy males
Intervention(s)		investigational material(s) Generic name etc : K-755 INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral dose control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral dose
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety adverse events, adverse drug reactions incidence rate
Secondary Outcome		safety clinical tests change from before administration

Primary Sponsor	Kowa Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Medical Corporation Heishinkai OPHAC Hospital
Address of IRB	4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Phone Number of IRB	+81-6-6395-9000
E-mail Address of IRB	sumiko.kawamoto@heishinkai.com
Status of IRB Review	approved
Date of Approval by IRB	Sept. 21, 2018

Secondary ID No.	JapicCTI-184132
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Sept. 10, 2019	(this page)	Changes
3	Dec. 17, 2018	Detail	Changes
2	Oct. 01, 2018	Detail	Changes
1	Oct. 01, 2018	Detail

List of change history