UMIN-CTR Clinical Trial

Basic information
Public title	Open-label study on safety and pharmacokinetics of [11C]thiamine in normal subjects
Acronym	PET pharmacokinetics of [11C]thiamine
Scientific Title	Open-label study on safety and pharmacokinetics of [11C]thiamine in normal subjects
Scientific Title:Acronym	PET pharmacokinetics of [11C]thiamine
Region	Japan

Condition
Condition	Normal subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of safety, dosimetry and whole-body pharmacokinetics of [11C]thiamine
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Safety (ECG, blood count, blood chemistry, urine at 90 min post injection)
Key secondary outcomes	Radiation exposure dosimetry Whole-body pharmacokinetics for 90min

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	PET imaging for 90min with single intravenous injection of [11C]thiamine (30-400MBq), which takes 4 hours in total including preparation and safety examinations.
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	65 years-old >
Gender	Male
Key inclusion criteria	1.Informed consent 2.Japanese male of 20y.o. or older and younger than 65y.o. 3.Body weight being 50kg or higher and lower than 85kg. BMI being 18.5 or higher and lower than 26.5 4.Healthy enough for this study
Key exclusion criteria	1)Allergy to drugs and/or foods 2)Serious disease in liver, kidney, heart, blood or vascular system. 3)Medication or dietary supplement within 7 days prior to PET scan. 4)Habitual intake of drugs or dietary supplements containing vitamin B1 or derivatives. Such intake within 1 month prior to PET scan. 5)Habitual heavy alcohol drinker or such intake within 7 days prior to PET scan. 6)Blood donation of 200mL or more within 1 month, 400mL or more within 3months 7)Should avoid further radiation exposure, based on radiation exposure history 8)Syphilis, HIV, Hepatitis B or C infection 9)Drug or alcohol abuse. 10)Inappropriate for a subject of this study for other reasons
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Michio Middle name Last name Senda
Organization	Kobe City Medical Center General Hospital
Division name	Molecular Imaging Research Group, Center for Clinical Research and Innovation
Zip code	650-0047
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
TEL	078-304-5212
Email	michio_senda@kcho.jp

Public contact
Name of contact person	1st name Kiyoshi Middle name Last name Irikura
Organization	Kobe City Medical Center General Hospital
Division name	Center for Clinical Research and Innovation
Zip code	650-0047
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
TEL	078-304-5212
Homepage URL
Email	irikura@fbri.org

Sponsor
Institute	Kobe City Medical Center General Hospital, Center for Clinical Research and Innovation
Institute
Department

Funding Source
Organization	Takeda Consumer Healthcare Company Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Riken
Name of secondary funder(s)	Foundation for Biomedical Research and Innovation

IRB Contact (For public release)
Organization	Kobe City Medical Center General Hospital IRB
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
Tel	078-302-4321
Email	rinken@kcho.jp

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	神戸市立医療センター中央市民病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 23 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035333
Publication of results	Unpublished

Result
URL related to results and publications	Unpublished
Number of participants that the trial has enrolled	3
Results	No adverse effects. Data acquisition was completed and was fixed.
Results date posted	2019 Year 07 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Normal subjects.
Participant flow	The subjects were enrolled after screening tests.
Adverse events	No adverse effects.
Outcome measures	Data analysis is on-going about evaluation of whole-body distribution and pharmacokinetics of [11C]thiamine together with dosimetry.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 19 Day
Date of IRB	2018 Year 01 Month 18 Day
Anticipated trial start date	2018 Year 01 Month 24 Day
Last follow-up date	2018 Year 03 Month 26 Day
Date of closure to data entry	2018 Year 04 Month 10 Day
Date trial data considered complete	2018 Year 04 Month 24 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 22 Day
Last modified on	2020 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035333

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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