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NCT05043766 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Oral PF614 Relative to OxyContin (PF614-102)
A Phase 1 study, sponsored by Ensysce Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT05043766: Completed Phase 1 study, sponsored by Ensysce Biosciences.
NCT05043766 is a Phase 1 study that has completed, run by Ensysce Biosciences. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05043766, a Phase 1 study, has completed, sponsored by Ensysce Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B). Both parts of the study will be conducted in healthy adult subjects.
Primary Outcome
Adverse Events, Significant Adverse Events, Adverse Events leading to discontinuation
Interventions
- DRUG Naltrexone Hydrochloride
- DRUG PF614
- DRUG OxyContin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2022-03-21 |
| Phase | Phase 1 |
What the finished NCT05043766 record still lists
NCT05043766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 3 interventions - of which Naltrexone Hydrochloride is the first listed.
NCT05043766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05043766 about?
NCT05043766 is a clinical study titled "Evaluation of Oral PF614 Relative to OxyContin (PF614-102)". This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B). Both parts of the study will be conducted in healthy adult subjects.
What is the current status of trial NCT05043766?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2021-09-08. Estimated completion is 2022-03-21.
What interventions are being tested in trial NCT05043766?
The interventions under investigation include: Naltrexone Hydrochloride (DRUG), PF614 (DRUG), OxyContin (DRUG).
Who is sponsoring clinical trial NCT05043766?
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 NCT05043766's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 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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