Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)

Launched by ENSYSCE BIOSCIENCES · Jul 8, 2024

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ClinConnect Summary

This clinical trial is studying how the body processes oxycodone, a pain medication, when taken alone and in combination with another drug called nafamostat. The goal is to understand how these medications behave in the body, which can help improve pain management in the future. The trial is currently recruiting healthy adults aged 18 to 55 who are willing to meet specific requirements, such as understanding the study details and agreeing to use contraception during the trial.

Participants in this study can expect to take either a single dose or multiple doses of the medications and will be monitored closely by healthcare professionals. To be eligible, individuals must not have serious allergies, significant health issues, or a history of substance abuse. This trial is important because it aims to gather valuable information that could lead to better and safer pain relief options for patients.

Gender

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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 and Part 3 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. Have poor venous access that limits phlebotomy.
• • 11. 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.
• • 12. Subjects with a positive fecal occult blood test at screening or baseline (Part 3 only).
• • 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.