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Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)

NCT02454712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-10-02

No results posted yet for this study

Summary

PF614 is an oxycodone prodrug that is designed for extended-release of oxycodone comparable to OxyContin. This Single Ascending Dose (SAD) study is designed to assess the safety and pharmacokinetics (PK) of PF614 in comparison to standard doses of OxyContin.

Conditions

  • Healthy

Interventions

DRUG

PF614

PF614 is an oxycodone prodrug

DRUG

Oxycodone extended-release

Oxycodone extended-release is the comparator drug

DRUG

Naltrexone Hydrochloride

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

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Ensysce Biosciences

    lead INDUSTRY

Principal Investigators

  • William K Schmidt, PhD · Ensysce Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-11-16
Primary Completion
2018-01-18
Completion
2018-01-18
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 NCT02454712 on ClinicalTrials.gov