Trials / Completed
CompletedNCT04474405
Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects
An Exploratory Evaluation of the Tau Protein Binding Properties, Whole-Body Biodistribution and Safety of 18F-AV-1451 Injection in Healthy Volunteers and Cognitively Impaired Subjects
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Avid Radiopharmaceuticals · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Accepted
Summary
This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-08-16
- Primary completion
- 2013-12-09
- Completion
- 2013-12-09
- First posted
- 2020-07-16
- Last updated
- 2020-09-25
- Results posted
- 2020-09-25
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04474405. Inclusion in this directory is not an endorsement.