UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of drug interactions of cytochrome P450 by single-substrate administrations and the cocktail method
Title of the study (Brief title)	Evaluation of drug interactions of cytochrome P450 by single-substrate administrations and the cocktail method
Region	Japan

Condition
Condition	drug interaction
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the changes of cytochrome P450 (CYP) activities (1A2, 2C9, 2C19, 2D6) evaluated between single-probe administrations and cocktail method after administrations of a CYP-inducer and CYP inhibitors.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacokinetics of caffeine, losartan omeprazole, dextromethorphan
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 inducer and inhibitor) inducer : rifampicin 450 mg s.i.d for 6 days before trial inhibitor : cimetidine 400mg b.i.d for 2 days before trial, fluvoxamine 25 mg b.i.d for 2days before trial
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	1 helthy male, over 20 years old 2 without hepatic disorder, renal disorder and disease under treatment 3 without medication allergy and idiosyncrasy 4 without drug dependence and alchol dependence 5 with consent to take part in this study by document
Key exclusion criteria	1 being unwellness 2 with abnormalities of bllod examination in advance 3 inadequateness to this study
Target sample size	24

Research contact person
Name of lead principal investigator	Hiroshi Watanabe
Organization	Hamamatsu University School of Medicine
Division name	Department of Clinical Pharmacology and Therapetics
Address	1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL	053-435-2385
Email	hwat@hama-med.ac.jp

Public contact
Name of contact person	Akio Hakamata
Organization	Hamamatsu University School of Medicine
Division name	Department of Clinical Pharmacology and Therapetics
Address	1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL	053-435-2385
Homepage URL
Email	hakamata@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Sports, Science, and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Parmacy Practice and Science, School of PharmaceuticalaScience, University of Shizuoka
Name of secondary funｄer(s)

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 12 Month 21 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 11 Month 12 Day
Anticipated trial start date	2015 Year 12 Month 21 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 21 Day
Last modified on	2016 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023423