UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009480 |
|---|---|
| Receipt number | R000011138 |
| Scientific Title | Clinical research of atorvastatin to evaluate the effect of OATP2B1 inhibition and drug-drug interaction |
| Date of disclosure of the study information | 2012/12/05 |
| Last modified on | 2013/12/04 12:03:08 |
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Basic information
Public title
Clinical research of atorvastatin to evaluate the effect of OATP2B1 inhibition and drug-drug interaction
Acronym
Clinical research of atorvastatin and OATP2B1
Scientific Title
Clinical research of atorvastatin to evaluate the effect of OATP2B1 inhibition and drug-drug interaction
Scientific Title:Acronym
Clinical research of atorvastatin and OATP2B1
Region
| Japan |
Condition
Condition
healthy male and female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess inhibitory effect of atorvastatin on OATP2B1 in healthy volunteer.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PK profiles of rosuvastatin, celiprolol, salazosulfapyridine, sumatriptan, glibenclamide and atorvastatin
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
substrate cocktail, wash out, with atorvastatin, wash out, with grapefruit juice
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The investigators must ensure that all subjects being considered meet the following inclusion criteria:
1) Japanese healthy male or female who is capable to understand and sign the
informed consent
2) 20-45 years of age
3) BMI 17.6-26.4
4) good health as determined by physical examination, vital signs and laboratory tests.
Key exclusion criteria
The investigators must ensure that all subjects being considered meet the following exclusion criteria or conditions:
1) history of allergy to any drugs
2) medical attention within 2 months prior to participation
3) donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation
4) donation of 400 mL or more of blood within 12 (male) or 16 (female) weeks prior to participation
5) recent (past 4 months) participation in other clinical trial for investigational new chemical entity
6) history of drug abuse
7) alcohol abuse
8) lactose intolerance.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Irie |
Organization
LTA
Division name
Kyushu Clinical Pharmacology Clinic
Zip code
Address
2-13-16 Jigyo Fukuoka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
LTA
Division name
Kyushu Clinical Pharmacology Clinic
Zip code
Address
TEL
092-733-1001
Homepage URL
Sponsor or person
Institute
Department of clinical pharmacokinetics, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2012 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 04 | Day |
Last modified on
| 2013 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011138
