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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026357
Receipt No. R000030285
Scientific Title Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Date of disclosure of the study information 2017/03/06
Last modified on 2018/08/29

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Basic information
Public title Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Acronym Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Scientific Title Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Scientific Title:Acronym Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Effective dose of [11C]K-2 in human
Key secondary outcomes The safety of [11C]K-2
The time-elapsed change of serum and urine radio activity
The time-elapsed change of unaltered compound and metabolites

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 [11C]K-2 370MBq
Interventions/Control_2 [11C]K-2 555MBq
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 male volunteer
2. Age is between 20-40
3. BMI is between 18.5-25.0
Key exclusion criteria (Exclusion criteria at the stage of screening)
1. The man who has past or current history of psychiatric disorder and another severe illness
2. Current smoker or past smoker who quit smoking within 6 months
3. The man who is disclosed brain disease by MRI study
4. The man who shows deviation from the standard in laboratory tests
5. The man whose eGFR is under 60
6. The man who has abnormal finding in ECG, brain MRI and vital signs
7. The man who is positive in infectious disease test
8. The man who can not undergo MRI and PET examination by reasons of metal inside the body, tattoos and claustphobia
9. The man who participates in clinical trial where he underwent nuclear medicine scan or CT scan within 6 months
10. The man who donates his blood 400ml within 12 weeks or 200ml within 4 weeks or more little within 2 weeks
11. The man who participates in other clinical trial within 3 months
12. The man who continues and cannot quit using drugs
13. The man who is suspected of alcohol hypersensitivity
14. The man who can not avoid impregnating during this trial
15. The man who is judged inadequate by the research medical doctor

(Exclusion criteria at the stage of pre-PET test)
1. The man who shows deviation from the standard in laboratory tests
2. The man who has abnormal finding in vital signs
3. The man who is judged inadequate by the research medical doctor
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Miyazaki
Organization Yokohama City University hospital
Division name Department of Physiology /Anesthesiology
Zip code
Address 3-9 Fukuura, Kanazawa-ward, Yokohama 236-0004
TEL 045-787-2579
Email johney@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name sayoko nakashima
Organization Yokohama City University
Division name Y-NEXT
Zip code
Address 1-1-1 Fukuura, Kanazawa-ward, Yokohama 236-0004
TEL 045-370-7994
Homepage URL
Email sayoko_n@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
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
2017 Year 03 Month 06 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
2017 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2017 Year 10 Month 30 Day
Date analysis concluded
2018 Year 02 Month 16 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 01 Day
Last modified on
2018 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030285

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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