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Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects

NCT04474405 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-09-25

Study results available
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Summary

This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Flortaucipir F18

IV injection, 370 MBq (10 mCi), single dose

PROCEDURE

Brain PET Scan

positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose).

PROCEDURE

Whole body PET scan

positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours

DRUG

Florbetapir F 18

IV injection, 370 MBq (10 mCi), single dose

PROCEDURE

Brain MRI

Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain

Sponsors & Collaborators

  • Avid Radiopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Medical Director · Avid Radiopharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-16
Primary Completion
2013-12-09
Completion
2013-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04474405 on ClinicalTrials.gov