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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030940
Receipt No. R000035333
Scientific Title Open-label study on safety and pharmacokinetics of [11C]thiamine in normal subjects
Date of disclosure of the study information 2018/01/23
Last modified on 2020/01/24

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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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