Unique ID issued by UMIN | UMIN000030940 |
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Receipt number | 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 09:31:45 |
Open-label study on safety and pharmacokinetics of [11C]thiamine in normal subjects
PET pharmacokinetics of [11C]thiamine
Open-label study on safety and pharmacokinetics of [11C]thiamine in normal subjects
PET pharmacokinetics of [11C]thiamine
Japan |
Normal subjects
Adult |
Others
NO
Evaluation of safety, dosimetry and whole-body pharmacokinetics of [11C]thiamine
Safety,Efficacy
Exploratory
Explanatory
Phase I
Safety (ECG, blood count, blood chemistry, urine at 90 min post injection)
Radiation exposure dosimetry
Whole-body pharmacokinetics for 90min
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Medicine |
PET imaging for 90min with single intravenous injection of [11C]thiamine (30-400MBq), which takes 4 hours in total including preparation and safety examinations.
20 | years-old | <= |
65 | years-old | > |
Male
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
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
3
1st name | Michio |
Middle name | |
Last name | Senda |
Kobe City Medical Center General Hospital
Molecular Imaging Research Group, Center for Clinical Research and Innovation
650-0047
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
078-304-5212
michio_senda@kcho.jp
1st name | Kiyoshi |
Middle name | |
Last name | Irikura |
Kobe City Medical Center General Hospital
Center for Clinical Research and Innovation
650-0047
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
078-304-5212
irikura@fbri.org
Kobe City Medical Center General Hospital,
Center for Clinical Research and Innovation
Takeda Consumer Healthcare Company Limited
Profit organization
Japan
Riken
Foundation for Biomedical Research and Innovation
Kobe City Medical Center General Hospital IRB
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
078-302-4321
rinken@kcho.jp
NO
神戸市立医療センター中央市民病院(兵庫県)
2018 | Year | 01 | Month | 23 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035333
Unpublished
Unpublished
3
No adverse effects.
Data acquisition was completed and was fixed.
2019 | Year | 07 | Month | 25 | Day |
Normal subjects.
The subjects were enrolled after screening tests.
No adverse effects.
Data analysis is on-going about evaluation of whole-body distribution and pharmacokinetics of [11C]thiamine together with dosimetry.
Completed
2017 | Year | 12 | Month | 19 | Day |
2018 | Year | 01 | Month | 18 | Day |
2018 | Year | 01 | Month | 24 | Day |
2018 | Year | 03 | Month | 26 | Day |
2018 | Year | 04 | Month | 10 | Day |
2018 | Year | 04 | Month | 24 | Day |
2020 | Year | 03 | Month | 31 | Day |
2018 | Year | 01 | Month | 22 | Day |
2020 | Year | 01 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035333
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