NCT02336360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

August 11, 2020

Completed
Last Updated

August 11, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

January 8, 2015

Results QC Date

July 27, 2020

Last Update Submit

July 27, 2020

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Urine Analysis

EXPERIMENTAL

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

Interventions

Flortaucipir F18DRUG

No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.

Also known as: 18F-AV-1451, [F-18]T807, LY3191748, Tauvid
Urine Analysis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Molecular NeuroImaging

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Medical Director
Organization
Avid Radiopharmaceuticals, Inc.
clinicaloperations@avidrp.com
215-298-0700

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 11, 2020

Results First Posted

August 11, 2020

Record last verified: 2020-07

Locations

US(1)