A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104)

Phase 1 Completed 32 enrolled Ensysce Biosciences Dr. Vince Clinical Research · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

This will be a randomized, double-blind, placebo- and active-controlled, 5-way crossover study to evaluate the abuse potential, safety and pharmacokinetics of orally administered PF614 relative to oxycodone IR (immediate-release) tablets and placebo.

Timeline

Start: 2022-10-05
Primary completion: 2022-12-23
Completion: 2022-12-28

Publications

Background Kirkpatrick DL, Evans C, Pestano LA, Millard J, Johnston M, Mick E, Schmidt WK. Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi-ascending dose study with a bioequivalence arm in healthy volunteers. Clin Transl Sci. 2024 Mar;17(3):e13765. doi: 10.1111/cts.13765.
Background Kirkpatrick DL, Schmidt WK, Morales R, Cremin J, Seroogy J, Husfeld C, Jenkins T. In vitro and in vivo assessment of the abuse potential of PF614, a novel BIO-MD prodrug of oxycodone. J Opioid Manag. 2017 Jan/Feb;13(1):39-49. doi: 10.5055/jom.2017.0366.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Oxycodone	Other / unclassified	40 mg	Oral
Subject	PF614	Unknown	50 mg	Oral
Subject	PF614	Unknown	100 mg	Oral
Subject	PF614	Unknown	200 mg	Oral

Indications

No indication recorded.