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NCT02454712 · ClinicalTrials.gov registry record · Phase 1
Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)
A Phase 1 study, sponsored by Ensysce Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT02454712: Completed Phase 1 study, sponsored by Ensysce Biosciences.
NCT02454712 is a Phase 1 study that has completed, run by Ensysce Biosciences. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02454712, a Phase 1 study, has completed, sponsored by Ensysce Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
PF614 is an oxycodone prodrug that is designed for extended-release of oxycodone comparable to OxyContin. This Single Ascending Dose (SAD) study is designed to assess the safety and pharmacokinetics (PK) of PF614 in comparison to standard doses of OxyContin.
Primary Outcome
Adverse events
Interventions
- DRUG Naltrexone Hydrochloride
- DRUG PF614
- DRUG Oxycodone extended-release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2016-11-16 |
| Est. Completion | 2018-01-18 |
| Phase | Phase 1 |
What the finished NCT02454712 record still lists
NCT02454712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Naltrexone Hydrochloride is the first listed.
NCT02454712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02454712 about?
NCT02454712 is a clinical study titled "Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)". PF614 is an oxycodone prodrug that is designed for extended-release of oxycodone comparable to OxyContin. This Single Ascending Dose (SAD) study is designed to assess the safety and pharmacokinetics (PK) of PF614 in comparison to standard doses of OxyContin.
What is the current status of trial NCT02454712?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2016-11-16. Estimated completion is 2018-01-18.
What interventions are being tested in trial NCT02454712?
The interventions under investigation include: Naltrexone Hydrochloride (DRUG), PF614 (DRUG), Oxycodone extended-release (DRUG).
Who is sponsoring clinical trial NCT02454712?
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 NCT02454712's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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