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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.

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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

FieldValue
Enrollment Target 64 participants
Start Date 2016-11-16
Est. Completion 2018-01-18
Phase Phase 1

Sponsor

Ensysce Biosciences

9 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.