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NCT02336360 Clinical Trial

Augmenting Flortaucipir Dosimetry Estimates

Alzheimer's Disease Clinical Trial

Official title:
A Multicenter Study to Obtain Data to Assist in Radiation Dosimetry Calculations From Subjects Enrolled in Human Studies Employing 18F-AV-1451

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02336360
Other study ID # 18F-AV-1451-A15
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2015
Est. completion date June 2015

Study information
Verified date July 2020
Source Avid Radiopharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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- Subjects who have withdrawn informed consent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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Flortaucipir F18
No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.

Locations
Country Name City State
United States Molecular NeuroImaging New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 0-360 minutes post injection
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