臨床研究等提出・公開システム

Date of registration	June. 19, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222121

Scientific Title	DS-7113b Phase I study -Evaluation of the safety, tolerability and pharmacokinetics of DS-7113b, and the effect of food on the pharmacokinetics of DS-7113b after a single dose of DS-7113b (immediate and extended release formulations) in healthy male Japanese subjects-
Public Title	Phase I study of DS-7113b

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	Daiichi Sankyo Co., Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		30
Study Type		Interventional
Study Design	Study Design	A single-center, open-label, single dose (part of the study is 2-way crossover).
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Male Japanese -Between the age of 20 and 45 -Between the BMI of 18.5 and 25.0
	Exclusion Criteria	-Presence or history of severe adverse reaction or sensitivity to any drug. -Presence or history of drug or alcohol abuse. etc.
	Minimum Age	20age old over
	Maximum Age	45age old under
	Gender	Male
Health Condition or Problem Studied		Healthy volunteers
Intervention(s)		investigational material(s) Generic name etc : DS-7113b INN of investigational material : Hydromorphone hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration for Investigational material : 1, 2, 4, 6mg, a single oral dose
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Pharmacokinetic parameters for free form and metabolites
Secondary Outcome

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

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-132167
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Mar. 29, 2018	Detail	Changes
5	Mar. 29, 2018	Detail	Changes
4	Aug. 06, 2014	Detail	Changes
3	Aug. 06, 2014	Detail	Changes
2	June. 19, 2013	Detail	Changes
1	June. 19, 2013	Detail

List of change history