UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quantification of histamine H3 receptor density in human brain using [11C]M-2
Title of the study (Brief title)	Quantification of histamine H3 receptor density in human brain
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Estimation of efficacy and safety of [11C]M-2 PET to quantify histamine H3 receptor density in human brain.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacokinetics and distribution volume of [11C]M-2 in human brain. Effective dose of [11C]M-2 in human
Key secondary outcomes	Relationship between the density of histamine H3 receptor and cognitive function

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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	[11C]M-2 PET
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	Healthy male
Key exclusion criteria	No history of psychiatric diseases
Target sample size	13

Research contact person
Name of lead principal investigator	Yasuyuki Kimura
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-3251
Email	y-kimura@nirs.go.jp

Public contact
Name of contact person	Kazuko Suzuki
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Address	4-9-1 Anagawa, Inage-ku, Chiba, Chiba 263-8555, Japan
TEL	043-206-3251
Homepage URL
Email	khsuzuki@nirs.go.jp

Sponsor
Institute	National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization	National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
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	2013 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 30 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 08 Month 08 Day
Last modified on	2016 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013375