UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficay assessment of adenosine A2A receptor ligand [C-11]Preladenant in healthy volunteers.
Title of the study (Brief title)	First-in-human study of [C-11] Preladenant.
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Neurology Radiology Neurosurgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	First-in-human study of [C-11]Preladenant. Assessment of safety, efficacy and dosimetry in healthy volunteers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Safety: Adverse Drug Reaction (symptoms, blood pressure, respiratory rate, heart rate, general blood tests) Efficacy: Quality and analyzability of PET/CT image. Dosimetry Date of evaluation: on the day and one week after the PET scan
Key secondary outcomes

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	The dosage in the vain of [C-11]CB184 for PET/CT imaging. Term of injection: On the day of PET/CT imaging. Dosage:185-740 MBq (Maximum substance at 37 microgram) Number of injection: once
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	60 years-old >=
Gender	Male
Key inclusion criteria	1. The subject who has intention to participate in this study, and signed informed consent. 2. Male subject of >=20 and =<60 years old. 3. The subject who judged by clinical investigator by means of physical examination and laboratory tests to be eligible as a participant in this study.
Key exclusion criteria	1. The subject who has dysfunction in the liver / kidney. 2. The subject who has abnormal findings in the central nervous system. 3. The subject having cardiac failure. 4. The subject with a history of a drug or food allergy. 5. The subject who juddged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size	15

Research contact person
Name of lead principal investigator	Kenji Ishii
Organization	Tokoyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Address	35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Email	ishii@pet.tmig.or.jp

Public contact
Name of contact person	Kenji Ishii
Organization	Tokoyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Address	35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Homepage URL
Email	ishii@pet.tmig.or.jp

Sponsor
Institute	Tokoyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Institute of Gerontology
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

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	地方独立行政法人東京都健康長寿医療センター研究所

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 14 Day
Anticipated trial start date	2015 Year 12 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 30 Day
Last modified on	2017 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023087