UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006797 |
|---|---|
| Receipt number | R000008047 |
| Scientific Title | Biodistribution and dosimetry of [11C]FLB457 in human |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2013/12/02 10:28:34 |
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Basic information
Public title
Biodistribution and dosimetry of [11C]FLB457 in human
Acronym
Biodistribution and dosimetry of [11C]FLB457 in human
Scientific Title
Biodistribution and dosimetry of [11C]FLB457 in human
Scientific Title:Acronym
Biodistribution and dosimetry of [11C]FLB457 in human
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate biodistribution and radiation safety profile of [11C]FLB457 in healthy humans
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Effective dose after injecting [11C]FLB457 in healthy humans
Key secondary outcomes
Biodistribution and radiation absorbed dose of each organs and the excretion pathway after injecting [11C]FLB457
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous injection of [11C]FLB457 (6mCi)
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 and Female
Key inclusion criteria
Healthy male volunteers (20 years or older) who do not have any psychiatric disorders or serious medical illnesses and who are able to understand an explanatory document and give consent are included in this study
Key exclusion criteria
-Under treatment of physical illness
-Having abnormal findings in physical examination and blood and urine tests
-Within 6 months after the last injection of radioisotopes
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kimura |
Organization
National Institute of Radiological Sciences
Division name
Molecular Neuroimaging Program, Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba, Chiba 263-8555, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Radiological Sciences
Division name
Molecular Neuroimaging Program, Molecular Imaging Center
Zip code
Address
TEL
Homepage URL
y-kimura@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
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
| 2011 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2011 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | 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
| 2011 | Year | 11 | Month | 30 | Day |
Last modified on
| 2013 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008047
| 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 |
