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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042987
Receipt No. R000049062
Scientific Title Urolithin A pharmacokinetic trial
Date of disclosure of the study information 2021/01/14
Last modified on 2021/01/13

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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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