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Evaluation of Oral PF614 Relative to OxyContin (PF614-102)

NCT05043766 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-09-24

No results posted yet for this study

Summary

This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B). Both parts of the study will be conducted in healthy adult subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

PF614

PF614 is an oxycodone prodrug

DRUG

Naltrexone Hydrochloride

Naltrexone HCl tablets, 50 mg, will be used to block the opioid effects in healthy volunteers

DRUG

OxyContin

Bioequivalence single-dose comparison to OxyContin

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Ensysce Biosciences

    lead INDUSTRY

Principal Investigators

  • William K Schmidt, PhD · Chief Medical Officer, Ensysce Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-08
Primary Completion
2022-03-21
Completion
2022-03-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05043766 on ClinicalTrials.gov