NCT05567354

A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103)

A Randomized, Double-blind, Placebo-and Active-Controlled Crossover Study to Evaluate the Intranasal Abuse Potential of PF614 Compared with Immediate-Release Oxycodone and Placebo in Non-Dependent Recreational Opioid Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Ensysce Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the abuse potential and pharmacokinetics of PF614 compared with a non-abuse deterrent, commercially available, immediate release (IR) oxycodone hydrochloride (HCl) formulation and placebo.

Detailed description

This will be a randomized, double-blind, placebo-and active-controlled, 3-way crossover study to evaluate the abuse potential and pharmacokinetics of intranasally administered PF614, relative to crushed oxycodone HCl IR tablets and placebo in non-dependent recreational opioid users. The study will consist of 4 phases: Screening, Qualification, Treatment, and Follow-up.

Conditions

• Recreational Drug Use

Interventions

Type	Name	Description
DRUG	PF614	PF614 100 mg capsules
DRUG	Oxycodone	Oxycodone HCl IR 40mg
OTHER	Placebo	placebo powder

Timeline

• Start date: 2022-06-10
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2022-10-05
• Last updated: 2024-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study