臨床研究等提出・公開システム

Date of registration	Nov. 02, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221293

Scientific Title	An open-label, add-on, drug-drug interaction study to assess the effect of FYX-051 on the pharmacokinetics and safety of warfarin in Japanese healthy adult male
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Sanwa Kagaku Kenkyusho Co., Ltd.
	Address	n_kuboyama@mb5.skk-net.com
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Sanwa Kagaku Kenkyusho Co., Ltd.
	Address	n_kuboyama@mb5.skk-net.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		12
Study Type		Interventional
Study Design	Study Design	Open-label, add-on study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Japanese healthy adult male
	Exclusion Criteria	Patients with any disease Subjects with any history of diseases that might affect the assessment in the study Subjects expressing the CYP2C9*3 genotype
	Minimum Age	20age old over
	Maximum Age	39age old under
	Gender	Male
Health Condition or Problem Studied		Healthy adult male
Intervention(s)		investigational material(s) Generic name etc : FYX-051 INN of investigational material : Therapeutic category code : 394 Agents for treatment of gout Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Pharmacokinetics and Safety
Secondary Outcome

Primary Sponsor	SANWA KAGAKU KENKYUSHO CO.,LTD.
Secondary Sponsor	Fuji Yakuhin Co., Ltd.

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-101330
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Dec. 21, 2011	Detail	Changes
3	Dec. 21, 2011	Detail	Changes
2	Nov. 02, 2010	Detail	Changes
1	Nov. 02, 2010	Detail

List of change history