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Trial record 1 of 1 for:    NCT02336360
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Augmenting Flortaucipir Dosimetry Estimates

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ClinicalTrials.gov Identifier: NCT02336360
Recruitment Status : Completed
First Posted : January 13, 2015
Results First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Alzheimer's Disease
Intervention Drug: Flortaucipir F18
Enrollment 6
Recruitment Details Enrollment occurred from Jan-Jun 2015 from Avid sponsored study 18F-AV-1451-A05 (NCT02016560)
Pre-assignment Details  
Arm/Group Title Urine Analysis
Hide Arm/Group Description Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Urine Analysis
Hide Arm/Group Description Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
68.2  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  16.7%
White
5
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Urine Analysis - Total Integrated Radioactivity Excreted in Urine
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Urine Analysis
Hide Arm/Group Description:
Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: megabecquerel-hours per megabecquerel
0.1413  (0.07216)
Time Frame AEs were not collected in this study
Adverse Event Reporting Description No subjects were administered a drug in this study. Therefore, participants at risk for adverse events in this study is zero.
 
Arm/Group Title Urine Analysis
Hide Arm/Group Description Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
All-Cause Mortality
Urine Analysis
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
Urine Analysis
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Urine Analysis
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Avid Radiopharmaceuticals, Inc.
Phone: 215-298-0700
EMail: clinicaloperations@avidrp.com
Layout table for additonal information
Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02336360    
Other Study ID Numbers: 18F-AV-1451-A15
First Submitted: January 8, 2015
First Posted: January 13, 2015
Results First Submitted: July 27, 2020
Results First Posted: August 11, 2020
Last Update Posted: August 11, 2020