Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ensysce Biosciences
• Collaborator: Quotient Sciences
• Treatments: Nafamostat; Naltrexone

Criteria

Inclusion Criteria:

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

2. Ages 18 to 55 years, inclusive, at time of signing informed consent

3. Body mass index of 18.0 to 32.0 kg/m2 as measured at screening or, if outside the range, considered not clinically significant by the investigator

4. Minimum weight of 50kg at screening

5. Must be willing and able to comply with all study requirements

6. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures

7. Must agree to use an adequate method of contraception

Exclusion Criteria:

1. 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

2. Subjects who are, or are immediate family members of, a study site or sponsor employee

3. Evidence of current SARS-CoV-2 infection

4. Subjects who have previously been administered IMP in this study

5. History of any drug or alcohol abuse in the past 2 years

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

7. A confirmed positive alcohol urine test at screening or admission

8. Current smokers and those who have smoked within the last 12 months. A confirmed positive urine cotinine test at screening or first admission

9. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months

10. Females of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at each admission

11. Females who are expected to have their menses during the dosing period

12. Male subjects with pregnant or lactating partners

13. Have poor venous access that limits phlebotomy

14. Clinically significant abnormal chemistry, hematology, coagulation, or urinalysis as judged by the investigator

15. Positive drugs of abuse test result

16. Positive hepatis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus antibody results

17. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator

18. Subjects with a history of cholecystectomy or gall stones

19. Subjects with a history of seizures

20. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

21. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active

22. Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication -