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

Recruiting now · Phase 1

Conditions studied: Pharmacokinetics, Healthy Volunteer

In brief

A single 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.

Key facts

Study ID

NCT06500793

Run by

Ensysce Biosciences

People needed

54

Starts

2024-11-24

Expected to finish

2027-04-28

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
• Must be willing and able to comply with all study requirements.
• Aged 18 to 55 years, inclusive, at time of signing informed consent.
• Must agree to use an adequate method of contraception (as defined in Section 9.4).
• Healthy males or non pregnant, non lactating healthy females.
• 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.
• Minimum weight of 50 kg at screening.

You may not qualify if…

• Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
• Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
• 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.
• Subjects with a history of seizures.
• Subjects with history of GI bleeding (excluding hemorrhoids) or history of peptic or duodenal ulcer disease.
• Subjects with a history of bleeding disorders or coagulopathy.
• 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).
• Parts 2 and 3 only: Subjects with a history of cholecystectomy or gall stones.
• Parts 2 and 3 only: Subjects with a history of opioid intolerance or hypersensitivity based on previous experience receiving any opioid analgesic
• Have poor venous access that limits phlebotomy.
• 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.
• Subjects with a platelet count <150,000/µL or international normalized ratio >1.1 at screening.
• Subjects with hemoglobin <LLN at screening and/or first admission.
• Subjects with a QT interval corrected using Fridericia's formula (QTcF) above 450 msec at screening and/or first admission.
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
• Positive serum pregnancy test at screening or first admission. Those who are pregnant or lactating will be excluded.
• 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.
• Subjects who have previously been administered IMP in this study.
• 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.
• Subjects with an anticipated need for requiring aspirin, non-steroidal anti-inflammatory drugs, or anticoagulants in the 14 days after administration of the IMP.
• History of any drug or alcohol abuse in the past 2 years.
• 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).
• A confirmed positive alcohol urine test at screening or first admission.
• Current smokers and those who have smoked within the last 12 months.

Where it is running

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

Full record on ClinicalTrials.gov

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