← Back to Search

Opioid Analgesic

PF614 solution for Pharmacokinetics (MPAR-101 Trial)

Phase 1
Waitlist Available
Led By Jeffrey Levy, MD, PhD
Research Sponsored by Ensysce Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 0.5,1,1.5,2,3,4,6,8,12,16,24,36,48 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new painkiller combination in healthy people. It includes a painkiller, a drug to manage its release, and another to block side effects. Researchers aim to see how these drugs are processed in the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.5,1,1.5,2,3,4,6,8,12,16,24,36,48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.5,1,1.5,2,3,4,6,8,12,16,24,36,48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetic AUC [Area Under the Curve]
Pharmacokinetic AUC(0-last)
Pharmacokinetic C24 [Plasma concentration at 24 hours]
+3 more
Secondary study objectives
Bioavailability AUC(0-inf)
Bioavailability AUC(0-last)
Bioavailability Cmax
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PF614 solution concomitantly with nafamostatExperimental Treatment3 Interventions
Cohort 1 and 6 will consist of 6 evaluable subjects. Subjects will receive the PF614 solution alone and concomitantly with nafamostat as an IR solution and/or ER prototype capsules. Subjects will receive naltrexone prior to and following each regimen. Cohorts 2 to 5 and Cohorts 7 to 10 will consist of 5 evaluable subjects in each cohort. Only 2 sentinel subjects will be dosed (one male and one female) in Period 2, Cohort 1. After review of the PK data and safety data, the safety advisory committee will decide the nafamostat dose level. After Cohorts 3 and 8 only: The fed vs fasted regimen will be determined for Cohorts 4 and 9.
Group II: PF614 solutionExperimental Treatment2 Interventions
Cohort 1 and 6 will consist of 6 evaluable subjects. Subjects will receive the PF614 solution alone and concomitantly with nafamostat as an IR solution and/or ER prototype capsules. Subjects will receive naltrexone prior to and following each regimen. Cohorts 2 to 5 and Cohorts 7 to 10 will consist of 5 evaluable subjects in each cohort. Only 2 sentinel subjects will be dosed (one male and one female) in Period 2, Cohort 1. After review of the PK data and safety data, the safety advisory committee will decide the nafamostat dose level. After Cohorts 3 and 8 only: The fed vs fasted regimen will be determined for Cohorts 4 and 9.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nafamostat Mesylate
2021
Completed Phase 1
~120
PF614 solution
2021
Completed Phase 1
~120
Naltrexone Hydrochloride
2021
Completed Phase 1
~330

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ensysce BiosciencesLead Sponsor
8 Previous Clinical Trials
590 Total Patients Enrolled
2 Trials studying Pharmacokinetics
67 Patients Enrolled for Pharmacokinetics
Quotient SciencesIndustry Sponsor
50 Previous Clinical Trials
1,463 Total Patients Enrolled
2 Trials studying Pharmacokinetics
69 Patients Enrolled for Pharmacokinetics
National Institute on Drug Abuse (NIDA)NIH
2,594 Previous Clinical Trials
3,328,625 Total Patients Enrolled
4 Trials studying Pharmacokinetics
153 Patients Enrolled for Pharmacokinetics
~28 spots leftby Dec 2025