Unique ID issued by UMIN | UMIN000004990 |
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Receipt number | R000005933 |
Scientific Title | Clinical study for PET microdose method by oral dose of [11C]Telmisartan in healthy volunteers |
Date of disclosure of the study information | 2011/02/01 |
Last modified on | 2012/07/20 16:09:49 |
Clinical study for PET microdose method by oral dose of [11C]Telmisartan in healthy volunteers
Pharmacokinetics of [11C]Telmisartan by oral dose in healthy volunteers (TEL-2)
Clinical study for PET microdose method by oral dose of [11C]Telmisartan in healthy volunteers
Pharmacokinetics of [11C]Telmisartan by oral dose in healthy volunteers (TEL-2)
Japan |
Healthy male subjects
Adult |
Others
NO
As telmisartan, an antihypertensive drug, is taken up by the liver through the OATP1B3 transporter, PET imaging with [11C]telmisartan may provide information about the liver pharmacokinetics of telmisartan as well as the function of OATP1B3.
The purpose of the study is to confirm whether the imaging result that is similar to the dosage of IV is provided by oral administration of [11C]Telmisartan.
Pharmacokinetics
Exploratory
Explanatory
Phase I
Plasma concentration time course and hepatobiliary pharmacokinetics of [11C]telmisartan.
Interventional
Single arm
Non-randomized
Open -no one is blinded
No treatment
1
Diagnosis
Medicine |
Oral administration of [11C]Telmisartan.
20 | years-old | <= |
45 | years-old | > |
Male
Normal subjects with body weight >= 50kg and <85kg, and body mass index >= 17.6 and <26.4.
1. Renal artery stenosis, bilaterally or unilaterally after nephrectomy
2. Hyperkalemia
3. Liver or renal dysfunction
4. Cerebrovascular disorders
5. Hypotension
6. Severe bradycardia, or WPW or LGL syndrome by ECG
7. Medication or dietary supplement including St. John's wort within 7 days prior to PET study
10
1st name | |
Middle name | |
Last name | Michio Senda |
Foundation for Biomedical Research and Innovation
Division of Molecular Imaging, Institute of Biomedical Research and Innovation
2-2 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
078(304)5212
1st name | |
Middle name | |
Last name | Michio Senda |
Foundation for Biomedical Research and Innovation
Division of Molecular Imaging, Institute of Biomedical Research and Innovation
2-2 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
078(304)5212
Foundation for Biomedical Research and Innovation
Association for Promoting Drug Development
Non profit foundation
Japan
RIKEN
TOKYO UNVERSITY GRADUATE SCHOOL
SETSUNAN UNVERSITY
NO
先端医療センター(兵庫県)
2011 | Year | 02 | Month | 01 | Day |
Unpublished
Terminated
2010 | Year | 12 | Month | 09 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 02 | Month | 01 | Day |
2012 | Year | 07 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005933
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