Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT05090280

Run by

Ensysce Biosciences

People needed

111

Starts

2021-12-01

Expected to finish

2023-04-26

Last updated by the study team

2024-09-24

Who can join

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

You may qualify if…

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

You may not qualify if…

• 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
• Subjects who are, or are immediate family members of, a study site or sponsor employee
• Evidence of current SARS-CoV-2 infection
• Subjects who have previously been administered IMP in this study
• 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
• A confirmed positive alcohol urine test at screening or admission
• Current smokers and those who have smoked within the last 12 months. A confirmed positive urine cotinine test at screening or first admission
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• Females of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at each admission
• Females who are expected to have their menses during the dosing period
• Male subjects with pregnant or lactating partners
• Have poor venous access that limits phlebotomy
• Clinically significant abnormal chemistry, hematology, coagulation, or urinalysis as judged by the investigator
• Positive drugs of abuse test result
• Positive hepatis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus antibody results
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator
• Subjects with a history of cholecystectomy or gall stones
• Subjects with a history of seizures
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
• Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication -

Where it is running

• Quotient Sciences — Miami, Florida, United States

Full record on ClinicalTrials.gov

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