臨床研究等提出・公開システム

Date of registration	June. 13, 2016
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223241

Scientific Title	Phase I Trial of YHI-1501 in Healthy Adult Japanese Subjects
Public Title	Phase I Trial of YHI-1501

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	Yakult Honsha Co., Ltd.
	Address	TEL: +81-3-5550-8966, FAX: +81-3-3248-5502
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		68
Study Type		Interventional
Study Design	Study Design	Randomized, single-center, double-blinded, placebo-controlled, dose-escalation study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1. Healthy male Japanese subjects 2. BMI of 18.5 kg/m^2 or more but less than 25.0 kg/m^2
	Exclusion Criteria	1. History of alcoholism 2. History of clinically significant drug or food allergies 3. History of surgery which affects oral drug absorption
	Minimum Age	20age old over
	Maximum Age	44age old under
	Gender	Male
Health Condition or Problem Studied		Healthy adult male
Intervention(s)		investigational material(s) Generic name etc : YHI-1501 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Oral administration control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety
Secondary Outcome		Pharmacodynamics and pharmacokinetics

Primary Sponsor	Yakult Honsha 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-163296
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	July. 11, 2017	Detail	Changes
7	July. 11, 2017	Detail	Changes
6	Mar. 01, 2017	Detail	Changes
5	Mar. 01, 2017	Detail	Changes
4	July. 04, 2016	Detail	Changes
3	July. 04, 2016	Detail	Changes
2	June. 13, 2016	Detail	Changes
1	June. 13, 2016	Detail

List of change history