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NCT05090280 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)
A Phase 1 study, sponsored by Ensysce Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 111
- Enrollment target
NCT05090280: Completed Phase 1 study, sponsored by Ensysce Biosciences.
NCT05090280 is a Phase 1 study that has completed, run by Ensysce Biosciences. The registered enrollment target is 111 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05090280, a Phase 1 study, has completed, sponsored by Ensysce Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 111 participants
- Enrollment target
Study Summary
A single dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is solution is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release (ER) capsule prototypes.
Primary Outcome
Time to maximum observed concentrations of oxycodone following administration of PF614 solution alone and with nafamostat
Interventions
- DRUG Naltrexone Hydrochloride
- DRUG Nafamostat Mesylate
- DRUG PF614 solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2023-04-26 |
| Phase | Phase 1 |
What the finished NCT05090280 record still lists
NCT05090280 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher).
The record links to 0 conditions, and to 3 interventions - of which Naltrexone Hydrochloride is the first listed.
NCT05090280 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05090280 about?
NCT05090280 is a clinical study titled "Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)". A single dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is solution is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release (ER) capsule prototypes.
What is the current status of trial NCT05090280?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2021-12-01. Estimated completion is 2023-04-26.
What interventions are being tested in trial NCT05090280?
The interventions under investigation include: Naltrexone Hydrochloride (DRUG), Nafamostat Mesylate (DRUG), PF614 solution (DRUG).
Who is sponsoring clinical trial NCT05090280?
This trial is sponsored by Ensysce Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05090280's enrollment target sits among peer trials
111 512th of 2000 higher than 1,487 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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