Unique ID issued by UMIN | UMIN000002446 |
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Receipt number | R000002983 |
Scientific Title | Radiation dosimetry, safety and pharmacokinetics of [11C]telmisartan as well as optimization of PET imaging in healthy volunteers |
Date of disclosure of the study information | 2009/09/07 |
Last modified on | 2010/03/18 10:20:39 |
Radiation dosimetry, safety and pharmacokinetics of [11C]telmisartan as well as optimization of PET imaging in healthy volunteers
Pharmacokinetics of [11C]telmisartan in healthy volunteers (TEL-0)
Radiation dosimetry, safety and pharmacokinetics of [11C]telmisartan as well as optimization of PET imaging in healthy volunteers
Pharmacokinetics of [11C]telmisartan in healthy volunteers (TEL-0)
Japan |
Hypertension
Cardiology | Radiology |
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 whole-body pharmacokinetics of telmisartan as well as the function of OATP1B3. The purpose of the study is to evaluate safety, pharmacokinetics and radiation dosimetry of [11C]telmisartan as well as to optimize the PET imaging procedure in normal subjects.
Pharmacokinetics
Exploratory
Explanatory
Phase I
Safety, radiation dosimetry, plasma concentration time course and whole-body pharmacokinetics of [11C]telmisartan.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Medicine |
To inject [11C]telmisartan intravenously for PET imaging.
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
9
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
Foundation for Biomedical Research and Innovation
Association for Promoting Drug Development (APDD)
Non profit foundation
Japan
RIKEN
NO
先端医療センター(兵庫県)
2009 | Year | 09 | Month | 07 | Day |
Unpublished
Completed
2009 | Year | 09 | Month | 03 | Day |
2009 | Year | 09 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2009 | Year | 09 | Month | 04 | Day |
2010 | Year | 03 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002983
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