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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
MPAR-101 Trial Summary
This trial will study how the body processes oxycodone when given alone or with nafamostat, an antifungal drug.
MPAR-101 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharmacokinetic AUC [Area Under the Curve]
Pharmacokinetic AUC(0-last)
Pharmacokinetic C24 [Plasma concentration at 24 hours]
+3 moreSecondary outcome measures
Bioavailability AUC(0-inf)
Bioavailability AUC(0-last)
Bioavailability Cmax
+1 moreMPAR-101 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
PF614 solution
2021
Completed Phase 1
~120
Naltrexone Hydrochloride
2021
Completed Phase 1
~330
Nafamostat Mesylate
2021
Completed Phase 1
~120
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Ensysce BiosciencesLead Sponsor
5 Previous Clinical Trials
224 Total Patients Enrolled
1 Trials studying Pharmacokinetics
17 Patients Enrolled for Pharmacokinetics
Quotient SciencesIndustry Sponsor
47 Previous Clinical Trials
1,307 Total Patients Enrolled
1 Trials studying Pharmacokinetics
19 Patients Enrolled for Pharmacokinetics
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,522 Total Patients Enrolled
4 Trials studying Pharmacokinetics
153 Patients Enrolled for Pharmacokinetics
Frequently Asked Questions
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