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This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urine Analysis | Experimental | Urine will be collected from subjects administered flortaucipir in an Avid-sponsored study to determine the amount of radioactivity excreted in urine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flortaucipir F18 | Drug | No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine Analysis - Total Integrated Radioactivity Excreted in Urine | Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations. | 0-360 minutes post injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Molecular NeuroImaging | New Haven | Connecticut | 06510 | United States |
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Enrollment occurred from Jan-Jun 2015 from Avid sponsored study 18F-AV-1451-A05 (NCT02016560)
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| ID | Title | Description |
|---|---|---|
| FG000 | Urine Analysis | Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Urine Analysis | Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urine Analysis - Total Integrated Radioactivity Excreted in Urine | Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations. | Posted | Mean | Standard Deviation | megabecquerel-hours per megabecquerel | 0-360 minutes post injection |
|
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AEs were not collected in this study
No subjects were administered a drug in this study. Therefore, participants at risk for adverse events in this study is zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Urine Analysis | Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | 215-298-0700 | clinicaloperations@avidrp.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |