臨床研究等提出・公開システム

Date of registration	June. 16, 2016
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223244

Scientific Title	An Open-Label, 3-Way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of DS-8500a in Japanese Healthy Subjects
Public Title	DS-8500a Food Effect Study

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		36
Study Type		Interventional
Study Design	Study Design	A single-center, randomized, open-label, single-dose, 3-way crossover study.
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Japanese -Between the age of 20 and 45 -Between the BMI of 18.5 and 25.0 -HbA1c < 6.5%
	Exclusion Criteria	-Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy) -People with drug or alcohol dependence. etc
	Minimum Age	20age old over
	Maximum Age	45age old under
	Gender	Both
Health Condition or Problem Studied		Healthy Volunteers
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 : 2 dose level (single oral dose of one 25 mg tablet or three 25 mg tablets)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		-Plasma concentrations and derived PK parameters for DS-8500a and a metabolite of DS-8500a.
Secondary Outcome		-Safety.

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-163299
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Dec. 22, 2016	Detail	Changes
5	Dec. 22, 2016	Detail	Changes
4	July. 25, 2016	Detail	Changes
3	July. 25, 2016	Detail	Changes
2	June. 16, 2016	Detail	Changes
1	June. 16, 2016	Detail

List of change history