Back to resultsA Study of 18F-AV-45 in Healthy Volunteers
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
florbetapir F 18
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
Eligibility 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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy Volunteers
Arm Description
Healthy male or female subjects, between 18 and 85 years of age.
Outcomes
Primary Outcome Measures
Whole Body Radiation Dosimetry
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01564706
Brief Title
A Study of 18F-AV-45 in Healthy Volunteers
Official Title
Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
Healthy male or female subjects, between 18 and 85 years of age.
Intervention Type
Drug
Intervention Name(s)
florbetapir F 18
Other Intervention Name(s)
18F-AV-45, Amyvid, florbetapir
Intervention Description
IV injection, 370MBq (10mCi), single dose
Primary Outcome Measure Information:
Title
Whole Body Radiation Dosimetry
Description
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.
Time Frame
0-380 min after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19406
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of 18F-AV-45 in Healthy Volunteers
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