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 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose, 0.5,1,1.5,2,3,4,6,8,12,16,24,36,48 hours

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

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