UMIN-CTR Clinical Trial

Basic information
Public title	Urolithin A pharmacokinetic trial
Acronym	Urolithin A pharmacokinetic trial
Scientific Title	Urolithin A pharmacokinetic trial
Scientific Title:Acronym	Urolithin A pharmacokinetic trial
Region	Japan

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

Objectives
Narrative objectives1	A comparative trial of the pharmacokinetics of Urolithin A based on blood, urine, and fecal concentrations after ingestion of Urolithin A containing foods in healthy adult men and women.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Comparative trial of blood Urolithin A concentration 2) Comparative trial of urinary Urolithin A concentration 3) Comparative trial of Urolithin A concentration in feces 4) Safety evaluation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single oral intake of 10 mg of test food
Interventions/Control_2	Single oral intake of 50 mg of test food
Interventions/Control_3	Single oral intake of 250 mg of test food
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Japanese healthy male and female applicants whose age at the time of obtaining consent is 40 years or older (male / female ratio 1: 1 or male <female) 2)Person with a BMI of 18.5 or more and less than 25.0 at the time of screening test 3)Those who are judged to be eligible as subjects of this study by the investigator, etc. in consideration of the results of the screening test 4)Those who have received sufficient explanation about the purpose and contents of this test, voluntarily volunteered, and consented in writing to participate in the test.
Key exclusion criteria	1) Those who are treated by a doctor or dentist 2) Persons with or have a history of hypersensitivity or idiosyncrasy to drugs or food 3) Person with allergic diseases such as bronchial asthma, hay fever, and atopic dermatitis 4) Those who have diseases in the heart, liver, kidney, digestive organs, respiratory organs, blood function, etc., or those who have a history of them or have a large surgical history, and are not eligible for this study by the investigator Those who are judged to be (excluding appendectomy) 5) Those who are or may be allergic to ellagic acid-containing foods (pomegranates, berries, nuts, etc.) 6) Those who are confirmed to be positive in the immunological test at the time of screening test 7) Person who regularly use foods for specified health use, foods with functional labeling foods and dietary supplements (supplement foods such as capsules) and cannot stop their intake at the time of obtaining consent. 8) Those who cannot keep smoking cessation during the period of admission and prohibition of drinking from 2 days before admission to the time of leaving 9) Those who cannot comply with not taking from ingesting ellagic acid-containing foods (pomegranates, berries, nuts, etc.) from 7 days before entering the hospital until leaving the hospital. 10) Those who have used or took the drug within 1 week before ingesting the test food, or those who need to use or take the drug
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Takazawa
Organization	Shinanozaka Clinic
Division name	Director of a clinic
Zip code	160-0017
Address	otsuya Medical Building 3F, 20 Samon-cho, Shinjuku-ku, Tokyo
TEL	0353663006
Email	takazawa@shinanokai.com

Public contact
Name of contact person	1st name Miki Middle name Last name Sasaki
Organization	Shinanozaka Clinic
Division name	Clinical Trial Department
Zip code	160-0017
Address	Yotsuya Medical Building 3F, 20 Samon-cho, Shinjuku-ku, Tokyo
TEL	0353663006
Homepage URL
Email	m-sasaki@shinanokai.com

Sponsor
Institute	Shinanozaka Clinic
Institute
Department

Funding Source
Organization	Daicel Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Shinanozaka Clinic Ethics Committee
Address	Yotsuya Medical Building 3F, 20 Samon-cho, Shinjuku-ku, Tokyo
Tel	0353663006
Email	m-iwasaki@shinanokai.com

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	医療法人社団信濃会 信濃坂クリニック Shinanozaka Clinic

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 14 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	Preinitiation
Date of protocol fixation	2020 Year 12 Month 07 Day
Date of IRB	2020 Year 12 Month 23 Day
Anticipated trial start date	2021 Year 01 Month 18 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 13 Day
Last modified on	2021 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049062

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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