臨床研究等提出・公開システム

Date of registration	Jan. 18, 2016
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223081

Scientific Title	An open-label, single-dose study to evaluate the pharmacokinetics and safety of DS-8500a in Japanese subjects with varying degrees of hepatic or renal function
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	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		48
Study Type		Interventional
Study Design	Study Design	A single-center, open-label, single dose
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	[Subjects must meet ALL of the following criteria for inclusion in the study] 1) Japanese male and female subjects, >= 20 years of age inclusive and with weight >= 45 kg for males and >= 40 kg for females and BMI < 30.0 kg/m2, inclusive, at screening. [In addition, subjects with normal and impaired hepatic functions must fulfill the following criteria] 2) AST/ALT or Estimated Child-Pugh Grade at screening within the categories shown below Normal hepatic function: AST/ALT < 2  ULN at screening Mild hepatic impairment: Child-Pugh Grade A, score 5 - 6 Moderate hepatic impairment: Child-Pugh Grade B, score 7 - 9 [In addition, subjects with normal and renal impaired functions must fulfill the following criteria] 3) Estimated eGFR(mL/min/1.73 m2) * within the categories shown below Normal renal function: eGFR > 90 Mild renal impairment: 60 =< eGFR < 90 Moderate renal impairment: 30 =< eGFR < 60 Severe renal impairment: 15 =< eGFR < 30 End-stage renal disease: eGFR < 15 or patients undergoing hemodialysis * : calculated using the eGFRcreat Formula
	Exclusion Criteria	[Subjects who meet any of the following criteria will be excluded from the study] 1) Presence or history of drug allergies or idiosyncratic drug response (such as to penicillin) 2) History of drug or alcohol abuse
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Subjects with hepatic or renal impairment
Intervention(s)		investigational material(s) Generic name etc : DS-8500a INN of investigational material : Therapeutic category code : 396 Antidiabetic agents 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	DAIICHI SANKYO 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-163135
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Jan. 25, 2017	Detail	Changes
5	Jan. 25, 2017	Detail	Changes
4	July. 25, 2016	Detail	Changes
3	July. 25, 2016	Detail	Changes
2	Jan. 18, 2016	Detail	Changes
1	Jan. 18, 2016	Detail

List of change history