UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025288 |
|---|---|
| Receipt number | R000029065 |
| Scientific Title | Clinical study on safety of PET probe targeting GLP-1 receptor |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2018/12/17 09:54:23 |
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Basic information
Public title
Clinical study on safety of PET probe targeting GLP-1 receptor
Acronym
Clinical study on safety of PET probe targeting GLP-1 receptor
Scientific Title
Clinical study on safety of PET probe targeting GLP-1 receptor
Scientific Title:Acronym
Clinical study on safety of PET probe targeting GLP-1 receptor
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluating for clinical safety of PET probe targeting GLP-1 receptor
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of frequency of adverse event and severity
Key secondary outcomes
Probe accumulation into pancreas
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
single dose (1 mCi)
1 day observation
Interventions/Control_2
single dose (2 mCi)
1 day observation
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
Key inclusion criteria
1) Healthy male who have no apparent glucose metabolism disorder. (fasting blood glucose level<100mg/dL and HbA1c<5.5%)
2) Over 20 years old
3) Agreement
Key exclusion criteria
1)BMI<18.5 or 30.0<
2)complication
severe renal dysfunction
pancreatic tumor
pancreatitis
3)past history
pancreatitis
pancreatic disease
4)unsuitable for and contraindication to Exenatide
5)alcohol intolerance
6)Inadequate patient judged by doctors
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuya Inagaki |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
Address
54, Kawaramachi, Shougoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3560
inagaki@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Fujimoto |
Organization
Kyoto University
Division name
Agency for Health, Safety and Environment
Zip code
Address
Yoshida-konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-7508
Homepage URL
fujimo57@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 03 | Month | 01 | 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
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 17 | 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
| 2016 | Year | 12 | Month | 15 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029065
