Study Summary
This trial will study how the body processes oxycodone when given alone or with nafamostat, an antifungal drug.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 4 Secondary · Reporting Duration: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,16,24,36,48 hours
24 hours
Pharmacokinetic C24 [Plasma concentration at 24 hours]
30 days
Incidence of Treatment-Emergent Adverse Effects [Safety and Tolerability]
pre-dose, 0.5,1,1.5,2,3,4,6,8,12,16,24,36,48 hours
Bioavailability AUC(0-inf)
Bioavailability AUC(0-last)
Bioavailability Cmax
Pharmacokinetic AUC [Area Under the Curve]
Pharmacokinetic AUC(0-last)
Pharmacokinetic Cmax [Maximum Plasma Concentration]
Pharmacokinetic T1/2 [Half-life]
Pharmacokinetic Tmax [Time to Maximum Plasma Concentration]
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
PF614 solution concomitantly with nafamostat
1 of 2
PF614 solution
1 of 2
Experimental Treatment
64 Total Participants · 2 Treatment Groups
Primary Treatment: PF614 solution · No Placebo Group · Phase 1
PF614 solution concomitantly with nafamostatExperimental Group · 3 Interventions: PF614 solution, Naltrexone Hydrochloride, Nafamostat Mesylate · Intervention Types: Drug, Drug, Drug
PF614 solutionExperimental Group · 2 Interventions: PF614 solution, Naltrexone Hydrochloride · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
FDA approved
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,16,24,36,48 hours
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
National Institute on Drug Abuse (NIDA)NIH
2,245 Previous Clinical Trials
5,619,336 Total Patients Enrolled
4 Trials studying Pharmacokinetics
153 Patients Enrolled for Pharmacokinetics
Quotient SciencesIndustry Sponsor
40 Previous Clinical Trials
1,104 Total Patients Enrolled
1 Trials studying Pharmacokinetics
19 Patients Enrolled for Pharmacokinetics
Maricer Escalon, MDPrincipal InvestigatorSenior Medical Director, Quotient Sciences
Maria Bermudez, MDPrincipal InvestigatorSenior Medical Director, Quotient Sciences
Eligibility Criteria
Age 18 - 55 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are a healthy male or non-pregnant, non-lactating female.
You are 18 to 55 years old.
You must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
References
- Kirkpatrick, PhD, D. Lynn, William K. Schmidt, PhD, Ricardo Morales, BSc, John Cremin, PhD, Julie Seroogy, BSc, Craig Husfeld, PhD, and Thomas Jenkins, PhD. 2017. “In Vitro and in Vivo Assessment of the Abuse Potential of PF614, a Novel BIO-MD™ Prodrug of Oxycodone”. Journal of Opioid Management. Weston Medical Publishing. doi:10.5055/jom.2017.0366.
- Kirkpatrick DL, Schmidt WK, Morales R, Cremin J, Seroogy J, Husfeld C, Jenkins T. In vitro and in vivo assessment of the abuse potential of PF614, a novel BIO-MD prodrug of oxycodone. J Opioid Manag. 2017 Jan/Feb;13(1):39-49. doi: 10.5055/jom.2017.0366.
- 2021. "Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05090280.
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Conditions
Cancer Related
Treatments