UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002477 |
|---|---|
| Receipt number | R000003036 |
| Scientific Title | Drug-drug interaction study to explore importance of CYP3A4 and OATP1B1 as factors determining pharmacokinetics of atorvastatin |
| Date of disclosure of the study information | 2009/09/10 |
| Last modified on | 2012/07/13 14:16:55 |
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Basic information
Public title
Drug-drug interaction study to explore
importance of CYP3A4 and OATP1B1 as factors determining pharmacokinetics of atorvastatin
Acronym
Drug-drug interaction study on atorvastatin
Scientific Title
Drug-drug interaction study to explore
importance of CYP3A4 and OATP1B1 as factors determining pharmacokinetics of atorvastatin
Scientific Title:Acronym
Drug-drug interaction study on atorvastatin
Region
| Japan |
Condition
Condition
healthy male subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the effects of functional variation of OATP1B1and CYP3A4 on pharmacokinetics of atorvastatin in japanese healthy subjects by using microdose.
Basic objectives2
Others
Basic objectives -Others
gene analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharmacokinetic of atorvastatin
Key secondary outcomes
pharmacokinetics of midazolam, pravastatin, itraconazole and rifampicin
gene analysis
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug administration(microdose of atorvastatin,midazolam,pravastatin)->(over 1week for washout)->Drug administration(clinical dose of rifampicin,microdose of atorvastatin, midazolam,pravastatin)->(over 1week for washout)->Drug administration(clinical dose of itraconazole,microdose of atorvasutatin, midazolam, pravastatin)
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1)Ability to understand and willing to sign the informed consent.
2)Japanese healthy male subjects age 20 to 40 years of age
3)Weight between 50-100kg.
4)Healthy subject as determined by medical history, physical examination, ECGs, and clinical laboratory tests.
Key exclusion criteria
1)Any hypersensitivities to atorvastatin,midazolam,pravastatin, straconazole or rifampicin.
2)hepatic disease requiring treatment.
3)acute narrow-angle glaucoma
4)QT prolongation over 460ms.
5)Use of medicine or health product including Saint John's wort 2 weeks before pre-dose.
6)Intake of fruit food and drink including grapefruit juice, orange juice or apple juice from 7 days before pre-dose.
7)Participation to any other clinical reseach in the past 3 months.
8)Donating over 200 ml of blood in the past 1 month or over 400ml of blood in the past 3 months.
9)Positive tests of serological reaction for syphilis, HIV antigen and antibody, HBs antigen or HCV antibody.
10)Any allergy to drug and food
11)Drug abuse or positive drug screening
12)Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Kumagai |
Organization
Kitsato University East Hospital
Division name
Clinical trial Center
Zip code
Address
2-1-1, Asamizodai, Sagamihara, Kanagawa, 228-8520
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitsato University East Hospital
Division name
Clinical trial Center
Zip code
Address
2-1-1, Asamizodai, Sagamihara, Kanagawa, 228-8520
TEL
Homepage URL
Sponsor or person
Institute
Clinical trial Center,Kitsato University East Hospital
Institute
Department
Personal name
Funding Source
Organization
APDD, Association for Promoting Drug Development
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
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
| 2009 | Year | 09 | Month | 10 | 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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 10 | Day |
Last modified on
| 2012 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003036
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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