Back to resultsAugmenting Flortaucipir Dosimetry Estimates
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Flortaucipir F18
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered
Exclusion Criteria:
- Subjects who have withdrawn informed consent
- Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials
Sites / Locations
- Molecular NeuroImaging
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Urine Analysis
Arm Description
Urine will be collected from subjects administered flortaucipir in an Avid-sponsored study to determine the amount of radioactivity excreted in urine.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02336360
First Posted
January 8, 2015
Last Updated
July 27, 2020
Sponsor
Avid Radiopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02336360
Brief Title
Augmenting Flortaucipir Dosimetry Estimates
Official Title
A Multicenter Study to Obtain Data to Assist in Radiation Dosimetry Calculations From Subjects Enrolled in Human Studies Employing 18F-AV-1451
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (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 obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urine Analysis
Arm Type
Experimental
Arm Description
Urine will be collected from subjects administered flortaucipir in an Avid-sponsored study to determine the amount of radioactivity excreted in urine.
Intervention Type
Drug
Intervention Name(s)
Flortaucipir F18
Other Intervention Name(s)
18F-AV-1451, [F-18]T807, LY3191748, Tauvid
Intervention Description
No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.
Primary Outcome Measure Information:
Title
Urine Analysis - Total Integrated Radioactivity Excreted in Urine
Description
Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.
Time Frame
0-360 minutes post injection
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered
Exclusion Criteria:
Subjects who have withdrawn informed consent
Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials
Facility Information:
Facility Name
Molecular NeuroImaging
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
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Augmenting Flortaucipir Dosimetry Estimates
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