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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01564706
First received: March 25, 2012
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.


Condition Intervention Phase
Alzheimer Disease
Drug: florbetapir F 18
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Whole Body Radiation Dosimetry [ Time Frame: 0-380 min after injection ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 9
Study Start Date: October 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01564706     History of Changes
Other Study ID Numbers: 18F-AV-45-A02
Study First Received: March 25, 2012
Results First Received: April 3, 2012
Last Updated: May 11, 2012
Health Authority: United States: Food and Drug Administration

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014