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A Study of 18F-AV-45 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01564706
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : April 30, 2012
Last Update Posted : May 18, 2012
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: florbetapir F 18 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45
Study Start Date : October 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy Volunteers
Healthy male or female subjects, between 18 and 85 years of age.
 Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir


Outcome Measures
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Primary Outcome Measures :
  1. Whole Body Radiation Dosimetry [ Time Frame: 0-380 min after injection ]
    Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine wall, small intestine wall, stomach wall, upper large intestine wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to lie still on the imaging table for periods up to 1 hour

Exclusion Criteria:

  • Radiation exposure for experimental purposes within the last year
  • Claustrophobic or otherwise unable to tolerate the imaging procedure
  • Medical condition or surgical history that would confound evaluation
  • Current clinically significant cardiovascular disease
  • Received an investigational medication within the last 30 days
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564706


Locations
United States, Pennsylvania
Research Site
Jenkintown, Pennsylvania, United States, 19406
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01564706     History of Changes
Other Study ID Numbers: 18F-AV-45-A02
First Posted: March 28, 2012    Key Record Dates
Results First Posted: April 30, 2012
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by Avid Radiopharmaceuticals:
Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders