UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004990
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

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Basic information

Public title

Clinical study for PET microdose method by oral dose of [11C]Telmisartan in healthy volunteers

Acronym

Pharmacokinetics of [11C]Telmisartan by oral dose in healthy volunteers (TEL-2)

Scientific Title

Clinical study for PET microdose method by oral dose of [11C]Telmisartan in healthy volunteers

Scientific Title:Acronym

Pharmacokinetics of [11C]Telmisartan by oral dose in healthy volunteers (TEL-2)

Region

Japan


Condition

Condition

Healthy male subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


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 confirm whether the imaging result that is similar to the dosage of IV is provided by oral administration of [11C]Telmisartan.

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

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Oral administration of [11C]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 or person

Institute

Foundation for Biomedical Research and Innovation

Institute

Department

Personal name



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
SETSUNAN UNVERSITY

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

2011 Year 02 Month 01 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

Terminated

Date of protocol fixation

2010 Year 12 Month 09 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 03 Month 01 Day

Date trial data considered complete

2011 Year 03 Month 01 Day

Date analysis concluded

2011 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 02 Month 01 Day

Last modified on

2012 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005933


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name