In vitro and in vivo assessment of the abuse potential of PF614, a novel BIO-MD™ prodrug of oxycodone.
D Lynn Kirkpatrick, William K Schmidt, Ricardo Morales...
https://pubmed.ncbi.nlm.nih.gov/28345745Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID06602271
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain After Abdominoplasty
Led by Ensysce Biosciences · Updated on 2026-01-22
320
Participants Needed
3
Research Sites
13 weeks
Total Duration
On this page
Sponsors
E
Ensysce Biosciences
Lead Sponsor
R
Rho, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the pain-relieving effects of PF614, an oral extended-release oxycodone prodrug, for controlling moderate to severe pain after abdominoplasty surgery. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to compare the effectiveness and safety of different doses of PF614 against placebo. The study includes several phases: screening, treatment, outpatient, and follow-up to thoroughly assess the medication's impact and tolerability. During the treatment phase, participants are admitted on the day of surgery and remain in the clinic for 5 days. They are randomly assigned to one of four groups receiving PF614 at doses of 25 mg, 37.5 mg, 50 mg, or placebo, given orally every 12 hours starting approximately one hour before surgery. The surgery involves a full abdominoplasty without liposuction, and participants receive a standardized anesthetic protocol including a transversalis abdominal plane block. Rescue pain medication is allowed under specific conditions. After the inpatient period, participants continue to record pain and any side effects at home for several days. Participants will rate their pain using a numerical scale at rest and with movement at scheduled times up to 5 days after surgery. Blood samples are collected to monitor drug levels, and sedation is assessed by trained staff. Safety is closely monitored during the inpatient stay, with follow-up visits scheduled about a week after surgery. The main outcome measured is the area under the curve of pain ratings over 48 hours, along with several secondary measures including rescue medication use, treatment satisfaction, and safety outcomes.
CONDITIONS
Brief Title
PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Male or female aged 18 to 75 years at screening
- Scheduled for full abdominoplasty without liposuction or other procedures
- Physical status rated I or II on the American Society of Anesthesiologists scale
- Body mass index between 18.0 and 32.0 kg/m2 and minimum weight of 50 kg
- Females must be postmenopausal, surgically sterile, or use approved birth control from 30 days before screening through 90 days after last study drug
- Males must agree to use approved contraception and partners of childbearing potential must use birth control from screening through 90 days after last study drug
- Able to speak, read, and understand English or Spanish
- Willing and able to follow study instructions and complete all study requirements
You will not qualify if you...
- Significant abnormalities or conditions that pose safety risks or affect study validity
- Serious cardiac, pulmonary, gastrointestinal, endocrine, metabolic (except diabetes with A1c ≤7.0), neurological, or psychiatric disorders
- History of malignancy within 2 years (except treated basal cell carcinoma)
- History or presence of acute respiratory depression, chronic pulmonary disease, or CNS depression
- History of seizure disorder or significant head injury
- Current painful condition that could affect study results
- History or presence of obstructive sleep apnea
- Known trypsin deficiency
- History of severe bronchial asthma, hypercarbia, or hypoxia
- Chronic gastrointestinal disease or major prior abdominal surgery affecting drug processing
- History of pancreatitis, pancreatic insufficiency, gastric ulcers, or gastrointestinal bleeding
- Clinically significant liver or kidney impairment
- Chronic opioid use exceeding 15 mg morphine equivalent per day for more than 3 days per week in the past year
- Recent use of analgesics or steroids before surgery
- Use of enzyme-modifying drugs or strong CYP inhibitors/inducers within 30 days
- Use of medications affecting analgesic response unless dose stable for 30 days
- Use of GLP-1 receptor agonists within 30 days
- Inability to discontinue prohibited medications
- History of substance or alcohol use disorder
- Positive drug or alcohol test at screening or surgery day
- Recent suicidal ideation or behavior
- Allergy to opioids, anesthetics, acetaminophen, or NSAIDs
- Pregnancy, lactation, or planning pregnancy within 30 days after last study drug
- Positive for hepatitis B, hepatitis C, or HIV
- Previous participation in PF614 trials
- Recent investigational drug or device use
- Any condition interfering with study or safety
- Employment or family relation to the sponsor or study site
- Considered unsuitable or unlikely to comply by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 28 days before the abdominoplasty procedure
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for medical screening and informed consent
Treatment
Duration - 5 days (4 nights) starting on the day of surgery
Participants undergo abdominoplasty surgery and receive the study drug or placebo while confined to the study center. Pain assessments and safety monitoring are conducted throughout.
Daily inpatient visits with continuous monitoring and pain assessments
Outpatient
Duration - From discharge until the follow-up visit 7 to 9 days after surgery
Participants manage pain at home and record medication use and pain levels in a diary after discharge from the study center.
Daily pain and medication diary entries until follow-up
Follow-up
Duration - 1 visit occurring 7 to 9 days after surgery
Participants return to the study center to complete assessments and submit their outpatient diaries.
1 visit (in-person) for final assessments and diary collection
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
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Research Team
W
William K Schmidt, PhD
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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Published Research Related To This Trial
Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi-ascending dose study with a bioequivalence arm in healthy volunteers.
D Lynn Kirkpatrick, Cari Evans, Linda A Pestano...
https://pubmed.ncbi.nlm.nih.gov/38511523