UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003960 |
|---|---|
| Receipt number | R000004772 |
| Scientific Title | A study to evaluate variation of the transporter in bile duct of plasma and tissue concentration among individual.(BSP-SG in bile with MRP2, OATP1B1, OATP1B3 genotypes) |
| Date of disclosure of the study information | 2010/07/28 |
| Last modified on | 2010/08/19 16:52:43 |
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Basic information
Public title
A study to evaluate variation of the transporter in bile duct of plasma and tissue concentration among individual.(BSP-SG in bile with MRP2, OATP1B1, OATP1B3 genotypes)
Acronym
A study of BSP-SG in bile and MRP2 OATP1B1 OATP1B3 genotypes
Scientific Title
A study to evaluate variation of the transporter in bile duct of plasma and tissue concentration among individual.(BSP-SG in bile with MRP2, OATP1B1, OATP1B3 genotypes)
Scientific Title:Acronym
A study of BSP-SG in bile and MRP2 OATP1B1 OATP1B3 genotypes
Region
| Japan |
Condition
Condition
healthy male subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The microdose study to evaluate the relationship of BSP-SG concentration in plasma and MRP2(rs12762549) genotypes and OATP1B1, OATP1B3 genotypes in healthy volunteers receiving BSP injection solution.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gene analysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
wild-wild
Group1: 3days iv 100microgram
Interventions/Control_2
wild-mutation
Group2: 3days iv 100microgram
Interventions/Control_3
mutation-mutation
Group3: 3days iv 100microgram
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
| 35 | 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) Body Mass Index (BMI):18.5~28.5
4) good health as determined by physical examination, vital signs and laboratory tests.
Key exclusion criteria
1) any medical condition that requires medical attention
2) impairments of liver or kidney functions
3) hepatic disease and history of this disease
4)Any hypersensitivitiies to BSP
(bromosulfophthalein)
5)Use of medicine or health product including Saint John's wort 2 weeks before pre-dose
6) Participation to any other clinical research in the past 3 months.
7) Donating over 200 ml of blood in the past 1 month or over 400ml of blood in the past 3 months.
8) Positive tests of serological reaction for syphilis, HIV antigen and antibody, HBs antigen or HCV antibody.
9) Any allergy to drug and food
10) history of drug or alcohol abuse screening
11) Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Kumagai |
Organization
Kitasato University East Hospital
Division name
Clinical trial Center
Zip code
Address
2-1-1, Asamizodai,minami-ku,sagamihara,kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato University East Hospital
Division name
Clinical trial Center
Zip code
Address
2-1-1, Asamizodai,minami-ku,sagamihara,kanagawa
TEL
Homepage URL
Sponsor or person
Institute
Clinical trial Center, Kitasato University East Hospital
Institute
Department
Personal name
Funding Source
Organization
APDD, Association for Promoting Drug Development
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 07 | Month | 28 | 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
| 2010 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | 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
| 2010 | Year | 07 | Month | 28 | Day |
Last modified on
| 2010 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004772
| 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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| Registered date | File name |
