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NCT03902548 · ClinicalTrials.gov registry record · Phase 1
Initial Investigation of [18F]P16-129 in Alzheimer's Disease Patients and Healthy Volunteers
A Phase 1 study, sponsored by Five Eleven Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT03902548: Completed Phase 1 study, sponsored by Five Eleven Pharma.
NCT03902548 is a Phase 1 study that has completed, run by Five Eleven Pharma. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03902548, a Phase 1 study, has completed, sponsored by Five Eleven Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
Quantitative estimates of amyloid distribution in brain - SUV and SUVR
Interventions
- DRUG [18F]P16-129
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2019-11-02 |
| Phase | Phase 1 |
What the finished NCT03902548 record still lists
NCT03902548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F]P16-129 is the first listed.
NCT03902548 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03902548 about?
NCT03902548 is a clinical study titled "Initial Investigation of [18F]P16-129 in Alzheimer's Disease Patients and Healthy Volunteers". 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.
What is the current status of trial NCT03902548?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2018-02-21. Estimated completion is 2019-11-02.
What interventions are being tested in trial NCT03902548?
The interventions under investigation include: [18F]P16-129 (DRUG).
Who is sponsoring clinical trial NCT03902548?
This trial is sponsored by Five Eleven Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03902548's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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