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UMIN-CTR Clinical Trial |
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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 |
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 | |
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Condition | ||
Condition | Normal subjects | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 3 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
michio_senda@kcho.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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. |
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Results date posted |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |