Overview

Clinical Evaluation of Flortaucipir F 18

Status:
Completed
Trial end date:
2019-06-26
Target enrollment:
0
Participant gender:
All
Summary
This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Avid Radiopharmaceuticals
Criteria
Subjects should meet inclusion and exclusion criteria for the companion protocol in
addition to the criteria below.

Inclusion Criteria:

- Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of
the companion study

Exclusion Criteria:

- Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or
endocrine disturbances

- Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if
male or QTc > 470 msec if female

- Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking
drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the
setting of intraventricular conduction block may be enrolled with sponsor approval

- Have a history of drug or alcohol dependence within the last year, or prior prolonged
history of dependence unless approved by the sponsor

- Are females of childbearing potential who are not surgically sterile, not refraining
from sexual activity or not using reliable methods of contraception

- Have a history of relevant severe drug allergy or hypersensitivity

- Are patients who have received an investigational medication within 30 days prior to
the planned imaging session for this study

- Are patients with current clinically significant unstable medical comorbidities

- Are patients who have received a radiopharmaceutical for imaging or therapy within the
past 24 hours prior to the imaging session for this study