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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

Tracking Information
First Submitted Date  ICMJE January 8, 2015
First Posted Date  ICMJE January 13, 2015
Results First Submitted Date  ICMJE July 27, 2020
Results First Posted Date  ICMJE August 11, 2020
Last Update Posted Date August 11, 2020
Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
Urine Analysis - Total Integrated Radioactivity Excreted in Urine [ Time Frame: 0-360 minutes post injection ]
Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2015)
Urine Analysis - Total integrated radioactivity excreted in urine [ Time Frame: 0-360 min post injection ]
Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Augmenting Flortaucipir Dosimetry Estimates
Official Title  ICMJE A Multicenter Study to Obtain Data to Assist in Radiation Dosimetry Calculations From Subjects Enrolled in Human Studies Employing 18F-AV-1451
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: Flortaucipir F18
No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.
Other Names:
  • 18F-AV-1451
  • [F-18]T807
  • LY3191748
  • Tauvid
Study Arms  ICMJE Experimental: Urine Analysis
Urine will be collected from subjects administered flortaucipir in an Avid-sponsored study to determine the amount of radioactivity excreted in urine.
Intervention: Drug: Flortaucipir F18
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2016)
6
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2015)
8
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02336360
Other Study ID Numbers  ICMJE 18F-AV-1451-A15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avid Radiopharmaceuticals
Study Sponsor  ICMJE Avid Radiopharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avid Radiopharmaceuticals
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP