Trial Outcomes & Findings for Augmenting Flortaucipir Dosimetry Estimates (NCT NCT02336360)
NCT ID: NCT02336360
Last Updated: 2020-08-11
Results Overview
Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
0-360 minutes post injection
Results posted on
2020-08-11
Participant Flow
Enrollment occurred from Jan-Jun 2015 from Avid sponsored study 18F-AV-1451-A05 (NCT02016560)
Participant milestones
| Measure |
Urine Analysis
Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Augmenting Flortaucipir Dosimetry Estimates
Baseline characteristics by cohort
| Measure |
Urine Analysis
n=6 Participants
Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
|
|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-360 minutes post injectionTotal integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.
Outcome measures
| Measure |
Urine Analysis
n=6 Participants
Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
|
|---|---|
|
Urine Analysis - Total Integrated Radioactivity Excreted in Urine
|
0.1413 megabecquerel-hours per megabecquerel
Standard Deviation 0.07216
|
Adverse Events
Urine Analysis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60