Actively Recruiting
Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
Led by Ensysce Biosciences · Updated on 2026-03-06
30
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
E
Ensysce Biosciences
Lead Sponsor
Q
Quotient Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Willing and able to follow all study requirements
- Aged 18 to 55 years at the time of consent
- Agree to use an adequate method of contraception
- Healthy males or healthy females who are not pregnant or lactating
- Body mass index between 18.0 and 32.0 kg/m2 or considered not clinically significant if outside this range
- Minimum weight of 50 kg at screening
You will not qualify if you...
- History of serious allergic reaction or hypersensitivity to drugs or formulation ingredients
- History of clinically significant allergy requiring treatment (except active hay fever)
- Significant serious skin diseases such as rash, eczema, psoriasis, or urticaria
- History of significant cardiovascular, kidney, liver, chronic respiratory, gastrointestinal disease, or neurological/psychiatric disorders
- History of seizures
- History of gastrointestinal bleeding or ulcers
- History of bleeding disorders or blood clotting problems
- Personal or family history of heart rhythm problems or significant cardiac disease
- History of cholecystectomy or gall stones (Part 2 only)
- History of opioid intolerance or hypersensitivity (Parts 2 and 3 only)
- Poor vein access limiting blood draws
- Abnormal laboratory tests judged clinically significant
- Low platelet count or abnormal clotting tests
- Low hemoglobin level
- Prolonged QTc interval on ECG
- Positive tests for hepatitis B, hepatitis C, or HIV
- Positive pregnancy test or currently pregnant/lactating
- Recent use of investigational medicinal products within 30 days or 5 half-lives
- Previous participation with investigational products in this study
- Use of prohibited medications or herbal remedies within 14 days prior to treatment
- Need for aspirin, NSAIDs, or anticoagulants within 14 days after treatment
- History of drug or alcohol abuse in past 2 years
- Regular alcohol use exceeding defined weekly limits
- Positive alcohol urine test
- Current or recent smokers or users of nicotine replacement products
- Positive urine cotinine or drug screen tests
- Male participants with pregnant or lactating partners
- Recent blood or plasma donation
- Immediate family members of study staff or sponsors
- Investigator judgment of unfitness for participation for any other reason
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Quotient Sciences
Miami, Florida, United States, 33126
Actively Recruiting
Research Team
W
William K Schmidt, PhD
CONTACT
L
Lynn Kirkpatrick, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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