臨床研究等提出・公開システム

Date of registration	Aug. 07, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080221878

Scientific Title	Pharmacokinetic study of TRK-820 -Pharmacokinetic study among TRK-820 tablets and TRK-820 soft capsules.-
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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Toray Industries,Inc.
	Address	Clinicaltrials-info@nts.toray.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		8
Study Type		Interventional
Study Design	Study Design	Single-facility, Randomized, Cross-over, Open Study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects over 20 and under 40 years of age. Subjects giving consent to enter the clinical trial.
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	39age old under
	Gender	Male
Health Condition or Problem Studied		Healthy Japanese Male
Intervention(s)		investigational material(s) Generic name etc : TRK-820T INN of investigational material : nalfurafine Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : single oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Evaluation of pharmacokinetics. Measurement of unaltered TRK-820 concentration in plasma and calculation of pharmacokinetic parameters.
Secondary Outcome		Evaluation of safety. Adverse Event(AE), Adverse Drug Reaction(ADR), Clinical Test, Vital Sign(VS), Electrocardiogram(ECG)(12-lead)

Primary Sponsor	Toray Industries,Inc.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name	Kyusyu Pharmacology Research Clinic Institutional Review Board
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-121923
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
6	Dec. 17, 2018	(this page)	Changes
5	Aug. 19, 2013	Detail	Changes
4	Aug. 19, 2013	Detail	Changes
3	Aug. 22, 2012	Detail	Changes
2	Aug. 07, 2012	Detail	Changes
1	Aug. 07, 2012	Detail

List of change history