UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PET measurement of hepatobiliary transport of Telmisartan in a therapeutic dose using [11C]Telmisartan in normal subjects as a determinant of nonlinear pharmacokinetics.
Title of the study (Brief title)	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	Michio Senda
Organization	Foundation for Biomedical Research and Innovation
Division name	Division of Molecular Imaging, Institute of Biomedical Research and Innovation
Address	2-2 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
TEL	078-304-5212
Email	senda@fbri.org

Public contact
Name of contact person	Yutaka Kaede
Organization	Foundation for Biomedical Research and Innovation
Division name	Ethics and Safety Section, Audit Dept.
Address	2-2 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan
TEL	078-306-0798
Homepage URL
Email	rinri@fbri.org

Sponsor
Institute	Foundation for Biomedical Research and Innovation
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009076