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
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease | Drug: florbetapir F 18 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | N/A |
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 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Pennsylvania | |
Research Site | |
Jenkintown, Pennsylvania, United States, 19406 |
Study Director: | Chief Medical Officer | Avid Radiopharmaceuticals |
Responsible Party: | Avid Radiopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01564706 |
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 |
Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |