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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003061
Receipt No. R000003712
Scientific Title Study for drug absorption from gastrointestinal tract #01: study with 2-[18F]fluoro-2-deoxy-D-glucose ([18F]FDG)
Date of disclosure of the study information 2010/01/19
Last modified on 2011/08/01

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Basic information
Public title Study for drug absorption from gastrointestinal tract #01: study with 2-[18F]fluoro-2-deoxy-D-glucose ([18F]FDG)
Acronym Oral administration PET #01
Scientific Title Study for drug absorption from gastrointestinal tract #01: study with 2-[18F]fluoro-2-deoxy-D-glucose ([18F]FDG)
Scientific Title:Acronym Oral administration PET #01
Region
Japan

Condition
Condition Healthy male subjects
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main purpose of this study is to investigate the usefulness of the technology for molecular imaging by PET as a new method to evaluate oral drug absorption in vivo.
In this study, the possibility of the application to the clinical area and the development of new drug is investigated using a PET probe, 2-[18F]Fluoro-2-deoxy-D-glucose ([18F]FDG)
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Time-course of drug concentration in the gastrointestinal tract (for 2 hours after oral administration)
Key secondary outcomes Time-course of drug concentration in the blood (for 2 hours after oral administration)

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 Number of subjects;25
Period of study; 2 days
1) Volunteers are fasted overnight.
2) Volunteers are administered a capsule containing [18F]FDG solution, and then PET scan and blood sampling are performed periodically.
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria 1) Healthy Japanese men at the age between 18 to 60 years, enable to be taken a PET scan for 90 minutes.
2) Volunteers will be attended by their own accordance and unforced by hierarchical relationships.
Key exclusion criteria The health history of gastroptosis
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tanaka, Masaaki
Organization Osaka City University Graduate School of Medicine
Division name Department of System Neuroscience
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka-shi, Osaka 545-8585, Japan
TEL 06-6645-3711
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashima, Tadayuki
Organization RIKEN
Division name Center for Molecular Imaging Science
Zip code
Address 6-7-3 Minatojima Minaminachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
TEL 078-304-7124
Homepage URL
Email ttakashima@riken.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization APDD
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 大阪市立大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.apdd-jp.org/nedo/NewsLetter_3_.pdf
Number of participants that the trial has enrolled
Results
PET imaging technique was applied to investigate oral absorption processes in the GI tract on healthy human subjects. 
It indicated that PET image analysis enabled the quantitative assessment of drug disposition in human GI tract after oral administration.
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 05 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 19 Day
Last modified on
2011 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003712

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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