UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007715 |
|---|---|
| Receipt number | R000009076 |
| Scientific Title | PET measurement of hepatobiliary transport of Telmisartan in a therapeutic dose using [11C]Telmisartan in normal subjects as a determinant of nonlinear pharmacokinetics. |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2016/08/24 09:11:38 |
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Basic information
Public title
PET measurement of hepatobiliary transport of Telmisartan in a therapeutic dose using [11C]Telmisartan in normal subjects as a determinant of nonlinear pharmacokinetics.
Acronym
Pharmacokinetics of [11C]Telmisartan under oral therapeutic dose in healthy volunteers (TEL-1B).
Scientific Title
PET measurement of hepatobiliary transport of Telmisartan in a therapeutic dose using [11C]Telmisartan in normal subjects as a determinant of nonlinear pharmacokinetics.
Scientific Title:Acronym
Pharmacokinetics of [11C]Telmisartan under oral therapeutic dose in healthy volunteers (TEL-1B).
Region
| Japan |
Condition
Condition
Healthy male subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
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 evaluate hepatobiliary pharmacokinetics in normal subjects.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Plasma concentration time course and hepatobiliary pharmacokinetics of [11C]telmisartan.
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
To inject [11C]Ttelmisartan intravenously for PET imaging in baseline and under oral administration of a single therapeutic dose of Telmisartan.
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male
Key inclusion criteria
Normal subjects with body weight >= 50kg and <85kg, and body mass index >= 17.6 and <26.4.
Key exclusion criteria
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
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Senda |
Organization
Foundation for Biomedical Research and Innovation
Division name
Division of Molecular Imaging, Institute of Biomedical Research and Innovation
Zip code
Address
2-2 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
TEL
078-304-5212
senda@fbri.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Kaede |
Organization
Foundation for Biomedical Research and Innovation
Division name
Ethics and Safety Section, Audit Dept.
Zip code
Address
2-2 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
TEL
078-306-0798
Homepage URL
rinri@fbri.org
Sponsor or person
Institute
Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
RIKEN
TOKYO UNVERSITY GRADUATE SCHOOL
KYUSHU UNIVERSITY GRADUATE SCHOOL
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
公益財団法人先端医療振興財団 先端医療センター(兵庫県)
Institute of Biomedical Research and Innovation
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 10 | Day |
Last modified on
| 2016 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009076
