UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042987 |
|---|---|
| Receipt number | R000049062 |
| Scientific Title | Urolithin A pharmacokinetic trial |
| Date of disclosure of the study information | 2021/01/14 |
| Last modified on | 2021/03/19 13:45:07 |
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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
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
m-sasaki@shinanokai.com
Sponsor or person
Institute
Shinanozaka Clinic
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 03 | Month | 19 | Day |
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 | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049062
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