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

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:

Genetics Home Reference related topics: Alzheimer disease

Drug Information available for: Florbetapir F-18

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

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 (Adult, Senior)
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


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 Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016

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