MedTrace Logo

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

NCT06629402 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-10-08

No results posted yet for this study

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 \[CPT\]).

Conditions

  • Acute Pain

Interventions

DRUG

PF614

Experimental oxycodone prodrug

DRUG

Placebo

Inactive medication

Sponsors & Collaborators

  • Dr. Vince Clinical Research

    collaborator OTHER

  • Ensysce Biosciences

    lead INDUSTRY

Principal Investigators

  • William K Schmidt, PhD · Ensysce Biosciences Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2023-11-14
Completion
2023-11-15
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 NCT06629402 on ClinicalTrials.gov