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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027705
Receipt No. 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 2019/06/14

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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
Email 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
Email wakimoto@ughp-cpc.jp

Sponsor
Institute Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

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
Email 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
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 No longer recruiting
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
2019 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 09 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031736

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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