Augmenting Flortaucipir Dosimetry Estimates

• Sponsor: Avid Radiopharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02336360
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

• Study Type: Interventional
• 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: Jan 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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• Subjects who have withdrawn informed consent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

Locations

	Site	City	State	Country	Postal Code
1	Molecular NeuroImaging	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Avid Radiopharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Avid Radiopharmaceuticals
• ClinicalTrials.gov Identifier: NCT02336360
• Other Study ID Numbers: 18F-AV-1451-A15
• First Posted: Jan 13, 2015
• Last Update Posted: Aug 11, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Alzheimer Disease

Study Results

Participant Flow

Recruitment Details	Enrollment occurred from Jan-Jun 2015 from Avid sponsored study 18F-AV-1451-A05 (NCT02016560)

Arm/Group Title	Urine Analysis
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

Baseline Characteristics

Arm/Group Title	Urine Analysis
Arm/Group Description	Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
Overall Participants	6
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.2 (11.5)
Sex: Female, Male (Count of Participants)
Female	2 33.3%
Male	4 66.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 16.7%
White	5 83.3%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Urine Analysis - Total Integrated Radioactivity Excreted in Urine
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Urine Analysis
Arm/Group Description	Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
Measure Participants	6
Mean (Standard Deviation) [megabecquerel-hours per megabecquerel]	0.1413 (0.07216)

Adverse Events

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
Arm/Group Description	Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis
All Cause Mortality
	Urine Analysis
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Urine Analysis
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Urine Analysis
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.