UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial to evaluate the efficacy and safety of [11C]K-2 in healthy volunteers
Title of the study (Brief title)	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	tomoyuki miyazaki
Organization	Yokohama city university, school of medicine
Division name	physiology
Address	Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2579
Email	johney@yokohama-cu.ac.jp

Public contact
Name of contact person	akane sano
Organization	Yokohama city university, school of medicine
Division name	physiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024205