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Opioid Analgesic

Oxycodone and Nafamostat for Pharmacokinetics

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

Minimum weight of 50kg at screening

Healthy males or non-pregnant, non-lactating healthy females

Must not have

Subjects who have received any Investigational Medical Product (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose

Regular alcohol consumption in males >21 units per week and females >14 units per week

Timeline

Screening 3 weeks

Treatment Varies

Follow Up parts 1 & 2 (pf614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. part 3 (pf614 bid doses): day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 12 hours; days 2-3 (predose); day 5 (predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how the body processes oxycodone when given alone and in combination with nafamostat in different forms like immediate-release solution and extended-release capsules.

Who is the study for?

This trial is for individuals who can safely receive oxycodone and PF614, a pain medication. Participants should not have any health conditions that interfere with drug absorption or processing.

What is being tested?

The study is testing how the body processes oxycodone when taken alone and together with nafamostat, both as an immediate-release solution and extended-release capsule, to understand their combined effects on pain relief.

What are the potential side effects?

Possible side effects may include nausea, dizziness, constipation, sleepiness, vomiting, itching and dry mouth from oxycodone; specific side effects of nafamostat are not detailed but could be similar.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 50kg.

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I am a healthy male or a non-pregnant, non-breastfeeding female.

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any experimental drugs in the last 30 days or within their half-life period.

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I drink more than the recommended weekly alcohol limit.

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I have had my gallbladder removed or have had gallstones.

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I have a history of seizures.

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My partner is currently pregnant or breastfeeding.

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I have difficult veins that make blood draws hard.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ parts 1 & 2 (pf614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. part 3 (pf614 bid doses): day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 12 hours; days 2-3 (predose); day 5 (predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~parts 1 & 2 (pf614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. part 3 (pf614 bid doses): day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 12 hours; days 2-3 (predose); day 5 (predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and parts 1 & 2 (pf614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. part 3 (pf614 bid doses): day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 12 hours; days 2-3 (predose); day 5 (predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 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(0-inf) [Area Under the Curve]

Pharmacokinetic AUC(0-last) [Area Under the Curve]

Pharmacokinetic C24 [Plasma concentration at 24 hours]

+3 more

Secondary study objectives

Incidence of Treatment-Emergent Adverse Effects [Safety and Tolerability]

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 capsule with naltrexone HClExperimental Treatment1 Intervention

PF614 is an oxycodone prodrug. Part 1 doses = 100, 300 and up to 500 mg. Subjects will receive single daily doses at 5-14 days apart. Naltrexone, 50 mg Oral (Day -1, Day 1 and Day 2). All subjects will receive naltrexone block

Group II: PF614 capsule concomitantly with nafamostat and naltrexone HClExperimental Treatment2 Interventions

PF614 is an oxycodone prodrug. Part 1 doses = 100, 300 and up to 500 mg. Nafamostat Mesylate is a trypsin inhibitor that blocks PF614 activation. Nafamostat IR solution (0.75 - XX mg); Nafamostat ER beads in capsule formulation (0.25 - YY mg) Naltrexone, 50 mg Oral (Day -1, Day 1 and Day 2). All subjects will receive naltrexone block

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nafamostat Mesylate

2021

Completed Phase 1

~120

0 / 9Eligibility criteria met