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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020975
Receipt No. 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

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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
Email 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
Email akane@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama city university, school of medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024205

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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