A Phase 1 interventional study of florbetapir F 18 in Alzheimer Disease, sponsored by Avid Radiopharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-18.
Sponsored by Avid Radiopharmaceuticals · Phase 1, Interventional, and Diagnostic
This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.
3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's enrollment of 9 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Avid Radiopharmaceuticals is the lead sponsor of 54 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Healthy male or female subjects, between 18 and 85 years of age.
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Also known as: 18F-AV-45, Amyvid, florbetapir
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.
Time frame: 0-380 min after injection
| Milestone | Healthy Volunteers |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
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.
| mSv/MBq | Healthy Volunteers |
|---|---|
| Effective Dose | 0.0186 ± 0.00426 |
| Adrenals | 0.0136 ± 0.00129 |
| Brain | 0.01 ± 0.00186 |
| Breasts | 0.00624 ± 0.000865 |
| Gallbladder Wall | 0.143 ± 0.0802 |
| Lower Large Intestine Wall | 0.0278 ± 0.0102 |
| Small Intestine | 0.0655 ± 0.0296 |
| Stomach Wall | 0.0117 ± 0.000906 |
| Upper Large Intestine Wall | 0.0745 ± 0.0342 |
| Heart Wall | 0.0131 ± 0.00159 |
| Kidneys | 0.013 ± 0.00111 |
| Liver | 0.0644 ± 0.0221 |
| Lungs | 0.00852 ± 0.000801 |
| Muscle | 0.00863 ± 0.000762 |
| Ovaries | 0.0176 ± 0.00434 |
| Pancreas | 0.0144 ± 0.00134 |
| Red Marrow | 0.0143 ± 0.00178 |
| Osteogenic Cells | 0.0276 ± 0.00371 |
| Skin | 0.00593 ± 0.000809 |
| Spleen | 0.0089 ± 0.000986 |
| Testes | 0.00681 ± 0.00129 |
| Thymus | 0.00727 ± 0.00122 |
| Thyroid | 0.00675 ± 0.00143 |
| Urinary Bladder Wall | 0.0271 ± 0.0117 |
| Uterus | 0.0156 ± 0.00319 |
| Total Body | 0.0116 ± 0.000951 |
Collected over AEs occuring within 3 days of injection; SAEs occuring within 30 days of injection. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Volunteers | — | 0/9 (0%) | 5/9 (55.6%) |
| Event | Healthy Volunteers |
|---|---|
| MUSCULOSKELETAL PAINMusculoskeletal and connective tissue disorders | 3/9 |
| NAUSEAGastrointestinal disorders | 2/9 |
| PALPITATIONSCardiac disorders | 1/9 |
| CHEST PAINGeneral disorders | 1/9 |
| BACK PAINMusculoskeletal and connective tissue disorders | 1/9 |
| ANXIETYPsychiatric disorders | 1/9 |
| Age Continuous(years) | Healthy Volunteers |
|---|---|
| Mean | 57.9 ± 10.31 |
| Sex: Female, Male(Participants) | Healthy Volunteers |
|---|---|
| Female | 6 |
| Male | 3 |
| Race/Ethnicity, Customized(participants) | Healthy Volunteers |
|---|---|
| Black | 1 |
| Caucasian | 8 |
| Region of Enrollment(participants) | Healthy Volunteers |
|---|---|
| United States | 9 |
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Avid Radiopharmaceuticals