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

PHASE1CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

April 26, 2023

Study Completion Date

April 26, 2023

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.

Trial Locations (1)

33126

Quotient Sciences, Miami

Sponsors
All Listed Sponsors
collaborator

Quotient Sciences

INDUSTRY

collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Ensysce Biosciences

INDUSTRY