UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003061 |
|---|---|
| Receipt number | 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 19:07:07 |
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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
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
ttakashima@riken.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003712
