UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034281 |
|---|---|
| Receipt number | R000039080 |
| Scientific Title | Analysis of blood metabolites after HBAIC1808 intake. |
| Date of disclosure of the study information | 2018/09/27 |
| Last modified on | 2019/12/20 12:18:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of blood metabolites after HBAIC1808 intake.
Acronym
Analysis of blood HBAIC1808 metabolites.
Scientific Title
Analysis of blood metabolites after HBAIC1808 intake.
Scientific Title:Acronym
Analysis of blood HBAIC1808 metabolites.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of blood metabolites after HBAIC1808 intake.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of HBAIC1808 metabolites after oral intake
Key secondary outcomes
Change of blood inflammatory markers after 3 weeks of HBAIC1808 administration.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
-Oral administration of a placebo capsule and collecting blood samples.
-Oral administration of an active drink every day for 3 weeks.
--Oral administration of an active capsule and collecting blood samples.
Interventions/Control_2
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male
Key exclusion criteria
-Subjects who go to hospital regularly or routinely taking oral medicine for disease: gastrointestinal system, liver, kidney, heart, and blood pressure.
-Subjects who had been took an antibiotic for over a week within 4 weeks.
-Subjects who are deemed inappropriate to participate in this study by the principle investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Murase |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan
TEL
+81-285-68-7460
murase.takatoshi@kao.com
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kuwano |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan
TEL
+81-285-68-7459
Homepage URL
kuwano.tetsuya@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@kao.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 27 | 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
10
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
| 2018 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 11 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2019 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039080
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
