Augmenting Flortaucipir Dosimetry Estimates

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Flortaucipir F18

• Registration Number: NCT02336360
• Lead Sponsor: Avid Radiopharmaceuticals

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 available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2020-07
• Results First Submitted: 2020-07-27
• Results First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Results First Posted: 2020-08-11
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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• Subjects who have withdrawn informed consent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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urine Analysis	Flortaucipir F18	Urine will be collected from subjects administered flortaucipir in an Avid-sponsored study to determine the amount of radioactivity excreted in urine.

Primary Outcome Measures

Name	Time	Method
Urine Analysis - Total Integrated Radioactivity Excreted in Urine	0-360 minutes post injection	Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.

Trial Locations

Locations (1)

Molecular NeuroImaging; 🇺🇸 New Haven, Connecticut, United States