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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
History of Changes

March 25, 2012
May 11, 2012
October 2007
January 2008   (final data collection date for primary outcome measure)
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.
Whole body radiation dosimetry [ Time Frame: 0-380 min after injection ] [ Designated as safety issue: Yes ]
Radiation dose values (millisievert/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.
Complete list of historical versions of study NCT01564706 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of 18F-AV-45 in Healthy Volunteers
Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45

This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Alzheimer Disease
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
Experimental: Healthy Volunteers
Healthy male or female subjects, between 18 and 85 years of age.
Intervention: Drug: florbetapir F 18
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01564706
18F-AV-45-A02
No
Avid Radiopharmaceuticals
Avid Radiopharmaceuticals
Not Provided
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
Avid Radiopharmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP