臨床研究等提出・公開システム

Date of registration	Oct. 07, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222622

Scientific Title	An open-label, non-randomized, single-sequence study to evaluate the effects of DS-8500a on the pharmacokinetics of midazolam in Japanese healthy subjects
Public Title	DS-8500a midazolam DDI 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	DAIICHISANKYO 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		28
Study Type		Interventional
Study Design	Study Design	A single-center, open-label, 1-sequence crossover study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1) Japanese 2) Between the age of 20 and 45 3) Between the BMI of 18.5 and 25.0 4) HbA1c < 6.5% 5) Between the fasting blood glucose level of 70 mg/dL and 109 mg/dL
	Exclusion Criteria	1) Presence or history of severe adverse reaction to any drug including midazolam or sensitivity. 2) Presence or history of drug or alcohol abuse. 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 : 1 dose level (Oral)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		The PK parameters of midazolam
Secondary Outcome		1) Other PK parameters of free form and metabolites of midazolam 2) The PK parameters of DS-8500a 3) Safety

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-142673
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Oct. 14, 2015	Detail	Changes
3	Oct. 14, 2015	Detail	Changes
2	Oct. 07, 2014	Detail	Changes
1	Oct. 07, 2014	Detail

List of change history