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

NCT05571345 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-09-24

No results posted yet for this study

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.

Conditions

  • Recreational Drug Use

Interventions

DRUG

PF614

PF614 capsules (50 mg or 100 mg)

DRUG

Oxycodone Hydrochloride 40 mg

Oral 20 mg tablets (two each)

DRUG

Placebo

Placebo to match PF614 capsules will be provided by the sponsor.

Sponsors & Collaborators

  • Dr. Vince Clinical Research

    collaborator OTHER

  • Ensysce Biosciences

    lead INDUSTRY

Principal Investigators

  • Lynn Kirkpatrick, PhD · Ensysce Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2022-12-23
Completion
2022-12-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05571345 on ClinicalTrials.gov