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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 is a Phase 1 study that has completed, run by Ensysce Biosciences. The registered enrollment target is 64 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02454712
The ClinicalTrials.gov registry entry for NCT02454712 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ensysce Biosciences, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Naltrexone Hydrochloride is the first listed.
NCT02454712 reports 0 study locations.
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.
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