Trials / Completed
CompletedNCT03902548
Initial Investigation of [18F]P16-129 in Alzheimer's Disease Patients and Healthy Volunteers
A Positron Emission Tomography (PET) Study to Compare the [18F]P16-129 and [18F]Florbetapir for Investigations of Amyloid β Pathology in Subjects With Alzheimer's Disease and Investigate the Biokinetics, Radiation Dosimetry, and Safety of [18F]P16-129 in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Five Eleven Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study investigates the initial safety profile of \[18F\]P16-129 in healthy volunteers including dosimetry determination, and compares the uptake and kinetics of \[18F\]P16-129 with the FDA approved drug \[18F\]florbetapir in the brains of Alzheimer's disease patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [18F]P16-129 | Injection of \< 10 mCi \[18F\]P16-129 followed by PET/CT scanning |
Timeline
- Start date
- 2018-02-21
- Primary completion
- 2019-11-02
- Completion
- 2019-11-02
- First posted
- 2019-04-04
- Last updated
- 2021-07-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03902548. Inclusion in this directory is not an endorsement.