111
Participants
Start Date
December 1, 2021
Primary Completion Date
April 26, 2023
Study Completion Date
April 26, 2023
PF614 solution
PF614 solution is an oxycodone prodrug
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.
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.
Quotient Sciences, Miami
Lead Sponsor
Quotient Sciences
INDUSTRY
National Institute on Drug Abuse (NIDA)
NIH
Ensysce Biosciences
INDUSTRY