A Study of Florbetapir (18F) in Japanese Healthy Volunteers
This study has been completed.
Eli Lilly and Company
Information provided by (Responsible Party):
First received: August 7, 2012
Last updated: July 16, 2013
Last verified: July 2013
This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed throughout the body of Japanese subjects.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||PET Whole Body Biodistribution Using Florbetapir (18F)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Avid Radiopharmaceuticals:
Primary Outcome Measures:
- Whole Body Radiation Dosimetry [ Time Frame: 0-360 minutes ] [ Designated as safety issue: Yes ]Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.
|Study Start Date:||August 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Healthy Volunteers
Cognitively normal, healthy volunteers at least 45 years of age.
Drug: florbetapir (18F)
IV injection, 370 MBq (10mCi), single dose
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