UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027705 |
|---|---|
| Receipt number | R000031736 |
| Scientific Title | Pharmacokinetic profile of ingested liver extracts in healthy volunteers. |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2023/05/11 09:20:09 |
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Basic information
Public title
Pharmacokinetic profile of ingested liver extracts in healthy volunteers.
Acronym
Pharmacokinetic profile of ingested liver extracts in healthy volunteers.
Scientific Title
Pharmacokinetic profile of ingested liver extracts in healthy volunteers.
Scientific Title:Acronym
Pharmacokinetic profile of ingested liver extracts in healthy volunteers.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify a pharmacokinetic profile of the absorbed components in serum after the ingestion of liver extracts.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentrations of peptides in the serum.
Key secondary outcomes
Safety evaluation including subjective symptoms, examination by a physician in charge.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of unblinded liver extracts
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
(1)Healthy Japanese males from 20 to 39 years of age when consented.
(2)Subjects whose height is 180 cm or less and BMI is 20.0 - 24.9 kg/m2.
(3)Subjects available at every designated hospital visit.
(4)Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria
(1)Subjects with hepatic, renal, cardiac or organ disorders, diabetes, or other serious diseases.
(2)Subjects with a surgical history of digestive system (except appendicectomy).
(3)Subjects with medication, or with exercise or dietary counselling by physician.
(4)Subjects who cannot tolerate repetitive blood drawings.
(5)Subjects who are participating in other clinical trial.
(6)Subjects who have experienced a feeling of unwellness or bad physical condition by blood drawing.
(7)Subjects judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Wakimoto |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
Homepage URL
wakimoto@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
ZERIA 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
Medical Corporation Hokubukai Utsukushigaoka Hospital institutional review board
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
011-882-0111
wakimoto@ughp-cpc.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
医療法人北武会 美しが丘病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
-
Publication of results
Unpublished
Result
URL related to results and publications
Published in only UMIN
Number of participants that the trial has enrolled
6
Results
Certain peptides increased in the bloodupon ingestion of test foods.
Results date posted
| 2023 | Year | 05 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy Volunteers
Participant flow
Subjects were selected based on the keyinclusion and exclusion criteria.
Adverse events
ND
Outcome measures
Concentrations of peptides in the serum.
Plan to share IPD
-
IPD sharing Plan description
-
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 08 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 08 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031736
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