Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)

Phase 2 Completed 16 enrolled Ensysce Biosciences Dr. Vince Clinical Research · collab

RandomizedCrossoverDouble-blindTreatment

Summary

The primary objective of the study is to evaluate the onset of analgesia following administration of a single oral dose of PF614 (50 mg or 100 mg) or placebo in healthy male subjects in an experimental pain model (cold pressor test \[CPT\]).

Timeline

Start: 2023-10-05
Primary completion: 2023-11-14
Completion: 2023-11-15

Publications

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.
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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF614	Unknown	50 mg	Oral
Subject	PF614	Unknown	100 mg	Oral

Indications

No indication recorded.