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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 Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Flortaucipir F18 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336360


Locations
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United States, Connecticut
Molecular NeuroImaging
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Avid Radiopharmaceuticals
More Information
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02336360    
Other Study ID Numbers: 18F-AV-1451-A15
First Posted: January 13, 2015    Key Record Dates
Results First Posted: August 11, 2020
Last Update Posted: August 11, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders