Normal subjects
Conditions
Interventions
PET imaging for 90min with single intravenous injection of [11C]thiamine (30-400MBq), which takes 4 hours in total including preparation and safety examinations.
Sponsors
Kobe City Medical Center General Hospital, Center for Clinical Research and Innovation
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (ECG, blood count, blood chemistry, urine at 90 min post injection) | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiation exposure dosimetry Whole-body pharmacokinetics for 90min | — |
Countries
Japan
Contacts
Public ContactKiyoshi Irikura
Kobe City Medical Center General Hospital Center for Clinical Research and Innovation
Outcome results
None listed