UMIN-CTR Clinical Trial

Basic information
Public title	Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
Acronym	Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
Scientific Title	Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
Scientific Title:Acronym	Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
Region	Japan

Condition
Condition	Healthy Volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the safety of healthy volunteers by continuously intake of foods containing SNR14.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(Safety evaluation) Blood test items,urinalysis items,general physical findings (subjective symptoms,objective findings),vital signs(blood pressure,pulse rate),physical measurements(body weight,body fat percentage,lean body mass),frequency of adverse events (Measurement item) Urinary excretion of SNR14,Plasma concentration of SNR14
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	4-weeks intake of SNR14-containing food
Interventions/Control_2	4-weeks intake of the placebo food
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Subjects who have obtained written consent for participation in the research. 2)Healthy men and women between 20 and 79. 3)Subject who can take meals, eat test foods, etc., take blood samples, take urine samples, and stay quiet and rest on the schedule indicated by investigators.
Key exclusion criteria	1)Subjects whose clinical inspection results are outside of the normal range and who are est imated inappropriate to this study. 2)Subjects who had a serious major organ / internal organ or who are currently undergoing treatment and who are estimated inappropriate to this study. 3)As a general rule, those who regularly use drugs for the purpose of treating diseases. 4)Subjects who have allergy. 5)Lactating people, pregnant women or those who may be pregnant, and those who wish to become pregnant during the study period. 6)Subjects who are estimated inappropriate to this study by principal investigator or investigators.
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	AMC Nishi-Umeda Clinic Ethical Review Committee
Address	West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel	06-4797-5660
Email	jimukyoku@amc-clinc.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2020 Year 09 Month 23 Day
Date of IRB	2020 Year 09 Month 24 Day
Anticipated trial start date	2020 Year 10 Month 05 Day
Last follow-up date	2020 Year 12 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 02 Day
Last modified on	2020 Year 11 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047905

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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