Assessing how oxycodone and PF614 work together with nafamostat

A Single Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 When PF614 Capsule is Co Administered With Nafamostat as a Combination IR Solution and ER Capsule Formulation in Healthy Subjects

This study is testing how well a new combination of oxycodone, PF614, and nafamostat works together to see if it can help prevent overdose in healthy adults aged 18 to 55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Ensysce Biosciences (Industry-sponsored)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT06500793 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics of oxycodone when administered alone and in combination with PF614 and nafamostat. It aims to determine the optimal dosing of PF614-MPAR, a combination of an oxycodone prodrug and a protease inhibitor, to provide overdose protection. Healthy volunteers aged 18 to 55 will receive single and multiple doses of the drug combinations, and their responses will be monitored to assess the impact of nafamostat on oxycodone release. The study builds on previous findings to refine the formulation for potential commercialization.

Who should consider this trial

Good fit: Ideal candidates are healthy males or non-pregnant, non-lactating females aged 18 to 55 with a BMI between 18.0 and 32.0 kg/m2.

Not a fit: Patients with serious allergies or hypersensitivity to drugs or formulations will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer pain management options with reduced risk of overdose.

How similar studies have performed: Previous studies have shown promise with similar formulations, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
2. Must be willing and able to comply with all study requirements.
3. Aged 18 to 55 years, inclusive, at time of signing informed consent.
4. Must agree to use an adequate method of contraception (as defined in Section 9.4).
5. Healthy males or non pregnant, non lactating healthy females.
6. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.
7. Minimum weight of 50 kg at screening.

Exclusion Criteria:

1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
3. Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
4. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease (Part 1 only: except cholecystectomy), gastrointestinal surgery (e.g. gastric bypass, gastric banding, colectomy), or neurological or psychiatric disorder, as judged by the investigator.
5. Subjects with a history of seizures.
6. Subjects with history of GI bleeding (excluding hemorrhoids) or history of peptic or duodenal ulcer disease.
7. Subjects with a history of bleeding disorders or coagulopathy.
8. Subjects with any personal history of arrhythmias or family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction prior to 50 years old).
9. Part 2 only: Subjects with a history of cholecystectomy or gall stones.
10. Parts 2 and 3 only: Subjects with a history of opioid intolerance or hypersensitivity based on previous experience receiving any opioid analgesic
11. Have poor venous access that limits phlebotomy.
12. Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1). Subjects with Gilbert's Syndrome are allowed.
13. Subjects with a platelet count \<150,000/µL or international normalized ratio \>1.1 at screening.
14. Subjects with hemoglobin \<LLN at screening and/or first admission.
15. Subjects with a QT interval corrected using Fridericia's formula (QTcF) above 450 msec at screening and/or first admission.
16. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
17. Positive serum pregnancy test at screening or first admission. Those who are pregnant or lactating will be excluded.
18. Subjects who have received any IMP in a clinical research study within 5 half lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IMP and first dose be less than 30 days.
19. Subjects who have previously been administered IMP in this study.
20. Subjects who are taking, or have taken, any prescribed or over the counter drug or herbal remedies (other than up to 4 g per day acetaminophen, HRT or hormonal contraception) in the 14 days before study treatment administration (see Section 11.4). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
21. Subjects with an anticipated need for requiring aspirin, non-steroidal anti-inflammatory drugs, or anticoagulants in the 14 days after administration of the IMP.
22. History of any drug or alcohol abuse in the past 2 years.
23. Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine).
24. A confirmed positive alcohol urine test at screening or first admission.
25. Current smokers and those who have smoked within the last 12 months.
26. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
27. A confirmed positive urine cotinine test at screening or first admission.
28. Positive drug screen test result at screening or first admission (drug of abuse tests are listed in Appendix 1).
29. Male subjects with pregnant or lactating partners.
30. Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study treatment.
31. Subjects who are, or are immediate family members of, a study site or sponsor employee.
32. Failure to satisfy the investigator of fitness to participate for any other reason.

Where this trial is running

Miami, Florida

• Quotient Sciences — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Jeffrey Levy, MD, PhD — Medical Director, Quotient Sciences
• Study coordinator: William K Schmidt, PhD

Conditions Pharmacokinetics