UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Title of the study (Brief title)	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	Tomoyuki Miyazaki
Organization	Yokohama City University hospital
Division name	Department of Physiology /Anesthesiology
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	sayoko nakashima
Organization	Yokohama City University
Division name	Y-NEXT
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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