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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006797
Receipt No. 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

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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
Email

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
Email y-kimura@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008047

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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