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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004019
Receipt No. R000004834
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 2010/08/10
Last modified on 2016/08/24

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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-1)
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-1)
Region
Japan

Condition
Condition Healthy male subjects
Classification by specialty
Not applicable
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 10

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
Email

Public contact
Name of contact person
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
Homepage URL
Email

Sponsor
Institute Foundation for Biomedical Research and Innovation
Institute
Department

Funding Source
Organization Association for Promoting Drug Development
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
Email

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 先端医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 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
2010 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2011 Year 09 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 09 Day
Last modified on
2016 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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