UMIN-CTR Clinical Trial

Basic information
Public title	PET Imaging-Based Evaluaion of Hepaobiliary transport in Humans with [18F]PTV
Acronym	PET study in Humans with [18F]PTV
Scientific Title	PET Imaging-Based Evaluaion of Hepaobiliary transport in Humans with [18F]PTV
Scientific Title:Acronym	PET study in Humans with [18F]PTV
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate hepatic uptake and subsequent canalicular efflux of [18F]PTV in healthy subjects.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Disribution of Radioacivity in human dbdominal region and blood after adminisration of [18F]PTV
Key secondary outcomes	metabolite analysis of human blood by TLC

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	This study includes PET scan for 2 times. For the first visit, the participants take only water.
Interventions/Control_2	For the second visit, they take livalo with water.
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	64 years-old >=
Gender	Male
Key inclusion criteria	healhy male who can have PET scan for about 90 min and temporal blood sampling for about 15 points.
Key exclusion criteria	1.those who have compligating disordes of severe cenral nervous system, liver, and kidney damage. 2.those who take hyperlipidemia treatment, tuberculosis drug and other treatments for target regions. 3.those who are claustrophobia. 4.those who are not suiable for this study assessed by medical docors judge
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Yasuyoshi Middle name Last name Watanabe
Organization	Osaka City Universiy / RIKEN Center for Biosystems Dynamics Research
Division name	Graduate School of Medicine
Zip code	545-8585 / 650-0047
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka / 6-7-3, Minatojima-minamimachi, Chuo-ku, Kobe
TEL	078-304-7101
Email	yywata@riken.jp

Public contact
Name of contact person	1st name Emi Middle name Last name Yamano
Organization	RIKEN Center for Biosystems Dynamics Research
Division name	Pathophysiological and Health Science Team
Zip code	650-0047
Address	6-7-3, Minatojima-minamimachi, Chuo-ku, Kobe
TEL	078-304-7124
Homepage URL
Email	emi.yamano@riken.jp

Sponsor
Institute	RIKEN Center for Biosystems Dynamics Research
Institute
Department

Funding Source
Organization	TAKEDA science foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Osaka City University Department of Nuclear Medicine, Osaka City University Department of Physiology, RIKEN
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Safety Center, RIKEN, Kobe
Address	2-2-3,minatojimaminamimachi chuo-ku kobe-city
Tel	078-306-0111
Email	siyaku@ml.riken.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	3849
Org. issuing International ID_1	The Ethics Committee of Osaka City University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪市立大学医学部附属病院　核医学科、大阪市立大学大学院医学研究科生理学第一

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 20 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 08 Month 31 Day
Date of IRB	2017 Year 10 Month 04 Day
Anticipated trial start date	2017 Year 11 Month 08 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 11 Month 20 Day
Last modified on	2022 Year 05 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034314