PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Ensysce Biosciences
Study ID
NCT06602271
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Postoperative Pain, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PF614 capsule — DRUG
    Experimental oxycodone prodrug
  • Placebo — DRUG
    Inactive medication

Study Details

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.

Key Dates

Start date
Dec 9, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PF614 25 mg
    Oral administration every 12 hours
  • Experimental: PF614 37.5 mg
    Oral administration every 12 hours
  • Experimental: PF614 50 mg
    Oral administration every 12 hours
  • Placebo Comparator: Placebo
    Oral administration every 12 hours

Primary Outcome Measure

Pain NRS-R area under the curve through 48 hours (AUC4-48) [ Time Frame: 4-48 hours ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
CenExel / Atlanta Center for Medical Research (ACMR)AtlantaGeorgia30331
Amber Tannahill, Recruitment Manager
[email protected]
404-214-0820
Jessica McCoun, MD (PRINCIPAL_INVESTIGATOR)
HD Research - Memorial Hermann Surgery CenterHoustonTexas77043
Alicia Ary
[email protected]
281-369-5765
Dominick D'Aunno, MD (PRINCIPAL_INVESTIGATOR)
CenExel / JBRSalt Lake CityUtah84107
Jenny Hunt, Recruitment Manager
[email protected]
801-261-2000
Todd M Bertoch, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
CenExel / Atlanta Center for Medical Research (ACMR)· Atlanta, GAHD Research - Memorial Hermann Surgery Center· Houston, TXCenExel / JBR· Salt Lake City, UT

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