Status:
RECRUITING
Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
Lead Sponsor:
Ensysce Biosciences
Collaborating Sponsors:
Quotient Sciences
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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-relea...
Detailed Description
PF614-MPAR is a combination of an oxycodone prodrug (PF614) and a protease inhibitor (nafamostat) that is intended to provide overdose protection when more than a prescribed dose may be taken simultan...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 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.
- 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).
- Part 2 only: Subjects with a history of cholecystectomy or gall stones.
- 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 positive fecal occult blood test at screening or baseline (Part 3 only).
- 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.
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
- A confirmed positive urine cotinine test at screening or first admission.
- Positive drug screen test result at screening or first admission (drug of abuse tests are listed in Appendix 1).
- Male subjects with pregnant or lactating partners.
- Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study treatment.
- Subjects who are, or are immediate family members of, a study site or sponsor employee.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Key Trial Info
Start Date :
November 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 27 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06500793
Start Date
November 24 2024
End Date
March 27 2026
Last Update
May 25 2025
Active Locations (1)
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1
Quotient Sciences
Miami, Florida, United States, 33126