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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016113
Receipt No. 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

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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
Email 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
Email kodagiri@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018719

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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