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Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)

NCT05090280 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2024-09-24

No results posted yet for this study

Summary

A single dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is solution is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release (ER) capsule prototypes.

Conditions

  • Pharmacokinetics

Interventions

DRUG

PF614 solution

PF614 solution is an oxycodone prodrug

DRUG

Naltrexone Hydrochloride

Naltrexone 50 mg has been selected to be administered on Day -1 (single dose), Day 1 (BID), and Day 2 (single-dose) to reduce opioid-related adverse effects.

DRUG

Nafamostat Mesylate

Maximum dose of 10 mg nafamostat co-administered with PF614 solution. Nafamostat will be dosed as an immediate-release (IR) solution or as prototype extended-release (ER) capsules.

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Ensysce Biosciences

    lead INDUSTRY

Principal Investigators

  • Jeffrey Levy, MD, PhD · Medical Director, Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-04-26
Completion
2023-04-26
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 NCT05090280 on ClinicalTrials.gov