UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016113 |
|---|---|
| Receipt number | R000018719 |
| Scientific Title | Influence of cytochrome P450 phenotypes on changes of drug-induced these enzyme activities |
| Date of disclosure of the study information | 2015/01/06 |
| Last modified on | 2016/01/05 09:04:41 |
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Basic information
Public title
Influence of cytochrome P450 phenotypes on changes of drug-induced these enzyme activities
Acronym
Influence of cytochrome P450 phenotypes on changes of drug-induced these enzyme activities
Scientific Title
Influence of cytochrome P450 phenotypes on changes of drug-induced these enzyme activities
Scientific Title:Acronym
Influence of cytochrome P450 phenotypes on changes of drug-induced these enzyme activities
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to evaluate the interactions between cytochrome P450 (CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A ) phenotypes and the changes of drug-induced these enzyme activities assessed by cocktail method.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cytochrome P450 1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Drugs (CYP inhibitor and inducer)
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
| Not applicable |
Gender
Male
Key inclusion criteria
Healthy adult males (older than age 20 years old)
Key exclusion criteria
(1) Liver dysfunction
(2) Renal dysfunction
(3) Inability to obtain informed consent
(4) Participant with diseases under treatment
(5) Drug allergy
(6) drug dependence or alcohol dependence
(7) Inappropriate participants due to other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
hwat@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Odagiri |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
Homepage URL
kodagiri@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2012 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 12 | Month | 04 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 05 | Day |
Last modified on
| 2016 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018719
