UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020975 |
|---|---|
| Receipt number | R000024205 |
| Scientific Title | Clinical trial to evaluate the efficacy and safety of [11C]K-2 in healthy volunteers |
| Date of disclosure of the study information | 2016/02/12 |
| Last modified on | 2016/11/08 16:50:24 |
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Basic information
Public title
Clinical trial to evaluate the efficacy and safety of [11C]K-2 in healthy volunteers
Acronym
Clinical trial to evaluate the efficacy and safety of [11C]K-2
Scientific Title
Clinical trial to evaluate the efficacy and safety of [11C]K-2 in healthy volunteers
Scientific Title:Acronym
Clinical trial to evaluate the efficacy and safety of [11C]K-2
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this trial is to evaluate the efficacy and safety of [11C]K-2, recognizing AMPA receptors, in healthy volunteers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure the dinamics and distribution volumes of [11C]K-2 in the brain.
Key secondary outcomes
To study the adverse event about [11C]K-2 during post 4-10 days after administration of it.
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
single administration of [11C]K-2
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1. japanese healthy volunteer
2. male
3. age is between 20-40
4. BMI is between 18.5-25.0
5. The laboratory data in the Blood test is within normal limit
6. HBV, HCV, HIV, syphilis negative
7. The man who can agree by himself
Key exclusion criteria
1. The man cannot agree by himself
2. The man who has past or current history of psychiatric disorder
3. current smoker or past smoker who quit smoking within 6 months
4. The man who is disclosed brain disease by MRI study
5. The man who has pacemaker or metal object inside his body
6. The man who has tatoo
7. claustrophobia
8. The man who participates in clinical trial where he underwent nuclear medicine scan within 6 months
9. The man who donates his blood 400ml within 12 weeks or 200ml within 4 weeks or more little within 2 weeks
10. The man who participates in other clinical trial within 12 weeks
11. The man who continues and cannot quit using drugs
12. The man who is judged inadequate by the research medical doctor
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | tomoyuki miyazaki |
Organization
Yokohama city university, school of medicine
Division name
physiology
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2579
johney@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | akane sano |
Organization
Yokohama city university, school of medicine
Division name
physiology
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2579
Homepage URL
akane@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university, school of medicine
Institute
Department
Personal name
Funding Source
Organization
Creation of innovation centers for advanced interdisciplinary research areas program
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
| 2016 | Year | 02 | Month | 12 | 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 | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 10 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 10 | Day |
Last modified on
| 2016 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024205
