RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A single and multiple-dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes.

Official Title

A Single and Multiple 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

Quick Facts

Study Start:2024-11-24

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06500793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

William K Schmidt, PhD

CONTACT

650-438-3018

wschmidt@ensysce.com

Lynn Kirkpatrick, PhD

CONTACT

281-881-4140

lkirkpatrick@ensysce.com

Principal Investigator

Jeffrey Levy, MD, PhD

PRINCIPAL_INVESTIGATOR

Medical Director, Quotient Sciences

Study Locations (Sites)

Quotient Sciences

Miami, Florida, 33126

United States

Collaborators and Investigators

Sponsor: Ensysce Biosciences

Jeffrey Levy, MD, PhD, PRINCIPAL_INVESTIGATOR, Medical Director, Quotient Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-24

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-11-24

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Pharmacokinetics