NCT06629402

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

A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ensysce Biosciences · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 \[CPT\]).

Detailed description

Researchers will compare drug PF614 to a placebo (a look-alike substance that contains no drug) to see if drug PF614 works to prevent moderate-to-severe experimental pain. Study subjects will: * On the Screening Day: Immerse their non-dominant hand in an ice cold water bath to assess their baseline pain threshold. Subjects will report when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes). * On Treatment Day 1: Repeat the initial CPT test for pain, then take drug PF614 or a placebo capsule (the study will be blinded so they won't know which treatment they received). After taking a single dose of study medication, they will be tested again for when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes) at 10 time periods up to 6 hours after taking the study medications. * Report adverse events, if any. * On Treatment Day 2: After a minimum of 5 days after Treatment Day 1, subjects will repeat the procedures from Treatment Day 1. They will receive the opposite medication that they received on Treatment Day 1 (this is a cross-over design). They will be tested again for when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes) at 10 time periods up to 6 hours after taking the study medications. * Report adverse events, if any.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	PF614	Experimental oxycodone prodrug
DRUG	Placebo	Inactive medication

Timeline

• Start date: 2023-10-05
• Primary completion: 2023-11-14
• Completion: 2023-11-15
• First posted: 2024-10-08
• Last updated: 2024-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study