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

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 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


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

Value
https://center6.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