UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019999 |
|---|---|
| Receipt number | R000023087 |
| Scientific Title | Safety and efficay assessment of adenosine A2A receptor ligand [C-11]Preladenant in healthy volunteers. |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2017/11/20 12:48:24 |
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Basic information
Public title
Safety and efficay assessment of adenosine A2A receptor ligand [C-11]Preladenant in healthy volunteers.
Acronym
First-in-human study of [C-11] Preladenant.
Scientific Title
Safety and efficay assessment of adenosine A2A receptor ligand [C-11]Preladenant in healthy volunteers.
Scientific Title:Acronym
First-in-human study of [C-11] Preladenant.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Neurology | Radiology | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
First-in-human study of [C-11]Preladenant. Assessment of safety, efficacy and dosimetry in healthy volunteers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety: Adverse Drug Reaction (symptoms, blood pressure, respiratory rate, heart rate, general blood tests)
Efficacy: Quality and analyzability of PET/CT image.
Dosimetry
Date of evaluation: on the day and one week after the PET scan
Key secondary outcomes
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
The dosage in the vain of [C-11]CB184 for PET/CT imaging.
Term of injection: On the day of PET/CT imaging.
Dosage:185-740 MBq (Maximum substance at 37 microgram)
Number of injection: once
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1. The subject who has intention to participate in this study, and signed informed consent.
2. Male subject of >=20 and =<60 years old.
3. The subject who judged by clinical investigator by means of physical examination and laboratory tests to be eligible as a participant in this study.
Key exclusion criteria
1. The subject who has dysfunction in the liver / kidney.
2. The subject who has abnormal findings in the central nervous system.
3. The subject having cardiac failure.
4. The subject with a history of a drug or food allergy.
5. The subject who juddged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Ishii |
Organization
Tokoyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
ishii@pet.tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Ishii |
Organization
Tokoyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
ishii@pet.tmig.or.jp
Sponsor or person
Institute
Tokoyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Institute of Gerontology
Organization
Division
Category of Funding Organization
Local Government
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
地方独立行政法人東京都健康長寿医療センター研究所
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | 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
| 2015 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | 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
| 2015 | Year | 11 | Month | 30 | Day |
Last modified on
| 2017 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023087
