UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026623 |
|---|---|
| Receipt number | R000021328 |
| Scientific Title | The analysis of the gene polymorphism in the variation factors of pharmacokinetics including drug transporters |
| Date of disclosure of the study information | 2017/03/21 |
| Last modified on | 2023/09/25 14:35:56 |
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Basic information
Public title
The analysis of the gene polymorphism in the variation factors of pharmacokinetics including drug transporters
Acronym
The polymorphism analysis of factors changing the pharmacokinetics
Scientific Title
The analysis of the gene polymorphism in the variation factors of pharmacokinetics including drug transporters
Scientific Title:Acronym
The polymorphism analysis of factors changing the pharmacokinetics
Region
| Japan |
Condition
Condition
genetic polymorphism
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To achieve a tailored medicine, we examine the types of gene polymorphisms and the extent of their activity in transporters that cause variations in the pharmacokinetics of drugs.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
mRNA expression levels of various transporters.
From sample collection until the end of the test.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Person who fully understands the purpose and safety of this research specified in consent and explanation of research and enter an agreement. Only those who signed agreement to cooperate shall be collaborators.
18 years and over.
Key exclusion criteria
A collaborator feels that the participation of research is a burden on everyday life.
Less than 18 years old.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takuo |
| Middle name | |
| Last name | Ogihara |
Organization
Takasaki University of Health and Welfare
Division name
Laboratory of Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences
Zip code
370-0033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma
TEL
027-352-1180
togihara@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuo |
| Middle name | |
| Last name | Ogihara |
Organization
Takasaki University of Health and Welfare
Division name
Laboratory of Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences
Zip code
370-0033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma
TEL
027-352-1180
Homepage URL
togihara@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board, University of Health and Welfare
Address
37-1 Nakaorui-machi, Takasaki-shi, Gunma
Tel
027-352-1290
mune@takasaki-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 21 | 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
| 2015 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
(1) Research type / design
Prospective observational study (Exploratory study by specimen)
(2) Sample collection from the subject and its measurement items
1 Collection of specimens
Genomic DNA extracted in pharmacokinetic practice
2 Measurement item
2-1 Transporter (P-gp, MRPs, BCRP, PEPTs, OATPs, OATs, OCTs)
2-2 Drug metabolizing enzymes (CYP3A4, 1A2, 2C9, 2C19, 2D6, 2E1, 3A5)
2-3 Plasma proteins (albumin, alpha 1-acid glycoprotein)
Polymorphism analysis in the above genes is performed.
Volunteers for healthy volunteers.No invasive action by this research participation will occur. Therefore, no anticipated adverse events and nonspecific adverse events are not observed where causality is not estimated.
Management information
Registered date
| 2017 | Year | 03 | Month | 21 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021328
