Actively Recruiting
PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)
Led by Ensysce Biosciences · Updated on 2026-01-22
320
Participants Needed
3
Research Sites
46 weeks
Total Duration
On this page
Sponsors
E
Ensysce Biosciences
Lead Sponsor
R
Rho, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the analgesic activity of PF614 (an oral oxycodone prodrug extended-release analgesic) for control of postsurgical pain in subjects scheduled for abdominoplasty surgery. The main question to be answered is: • To assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate to severe pain following abdominoplasty. Participants will be asked to take oral blinded doses of study medication at about one hour before surgery starts, and then every 12 hours after surgery for up to 4 days. Participants will be asked to: * Rate their pain on a 0-10 numerical rating scale (NRS) at various timepoints up to 5 days following surgery; * Tell us about the need for rescue medication if they continue to have moderate-to-severe pain; * Tell us about any side effects or adverse effects that they may experience to help us understand the safety and tolerability of the test medications; * Provide periodic blood samples to help us understand how much study drug is in their system. Participants will stay in a clinic setting and be monitored for safety for 5 days following surgery. We anticipate that participants will be discharged on Day 5, pending medical review, and then keep a diary to record study-related pain and adverse effects for an additional 2-4 days after discharge.
CONDITIONS
Official Title
PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before starting any study procedures
- Be male or female between 18 and 75 years old
- Scheduled for a full abdominoplasty surgery without liposuction and no other procedures
- Have a physical status classified as I or II by the American Society of Anesthesiologists
- Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 and weigh at least 50 kg
- If female, be either not of childbearing potential or use acceptable birth control from 30 days before screening to 90 days after last medication
- If male, agree to use acceptable contraception and ensure female partners use contraception during the same period
- Be able to speak, read, and understand English or Spanish well enough to complete study assessments
- Be willing and able to follow study instructions and complete all study requirements
You will not qualify if you...
- Have any clinically significant abnormality or medical condition that could risk safety or affect study results
- Have significant heart, lung, gastrointestinal, endocrine, metabolic (except diabetes with A1c ≤7.0), neurological, or psychiatric disorders
- Have had cancer in the past 2 years (except treated basal cell carcinoma)
- Have acute respiratory depression or severe pulmonary diseases
- Have a history of seizures or significant head injury
- Have ongoing painful conditions that may interfere with study assessments
- Have obstructive sleep apnea
- Have trypsin deficiency
- Have acute or severe asthma, high carbon dioxide levels, or low oxygen levels
- Have chronic gastrointestinal diseases or major previous abdominal surgeries that affect drug absorption
- Have a history of pancreatitis, pancreatic insufficiency, gastric ulcers, or gastrointestinal bleeding
- Have significant liver or kidney impairment
- Have used chronic opioid therapy exceeding 15 mg morphine equivalents for over 1 month in the past year
- Have taken analgesics or NSAIDs recently before surgery beyond allowed limits
- Have taken systemic steroids within 3 months before the study
- Have used enzyme-modifying drugs affecting liver enzymes within 30 days before study drug
- Have used medications that could affect pain response not stable for at least 30 days
- Have used GLP-1 receptor agonists within 30 days before study drug
- Cannot stop prohibited medications
- Have a substance or alcohol use disorder
- Have positive drug or alcohol tests at screening or surgery day
- Have recent suicidal thoughts or behavior
- Are allergic to opioids, anesthetics, acetaminophen, or NSAIDs
- Are pregnant, breastfeeding, or planning pregnancy within 30 days after study drug
- Have hepatitis B, hepatitis C, or HIV
- Previously participated in PF614 trials
- Used investigational drugs or devices within 4 weeks before study drug
- Have any condition that may interfere with study or safety
- Are employees or immediate family of study staff or sponsor
- Are considered unsuitable or unlikely to comply with study protocol
AI-Screening
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Trial Site Locations
Total: 3 locations
1
CenExel / Atlanta Center for Medical Research (ACMR)
Atlanta, Georgia, United States, 30331
Actively Recruiting
2
HD Research - Memorial Hermann Surgery Center
Houston, Texas, United States, 77043
Actively Recruiting
3
CenExel / JBR
Salt Lake City, Utah, United States, 84107
Actively Recruiting
Research Team
W
William K Schmidt, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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