📋 Eligibility rules (as published)
Inclusion Criteria:
1. Participant must provide written informed consent prior to the initiation of any protocol specific procedures.
2. Male or female participant, between 18 and 75 years of age, inclusive, at the time of Screening.
3. Participant must be scheduled to undergo a full abdominoplasty procedure without liposuction with no collateral procedures.
4. Participant must have physical status rated as I-II on the American Society of Anesthesiologists rating scale.
5. Participant must have a body mass index (BMI) within 18.0 to 32.0 kg/m2, inclusive (minimum weight of at least 50.0 kg).
6. If female, participant must be either not of childbearing potential (defined as postmenopausal for at least 1 year and confirmed with follicle stimulating hormone \[FSH\] \>40 mIU/mL as deemed necessary by the investigator, or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or participant must use a medically acceptable method of birth control (oral or transdermal hormonal contraceptives; vaginal ring; contraceptive implant or injection; intrauterine contraceptive system \[with or without hormone\]; condom and spermicidal foam; heterosexual abstinence; or sterilization of partner) from 30 days prior to Screening through 90 days after the last study drug administration. Heterosexual abstinence is considered to be a highly effective method only if the participant agrees to refrain from heterosexual intercourse during the entire period from 30 days prior to Screening to 90 days after the last study drug administration.
7. If male, participant must agree to use medically acceptable methods of contraception (diaphragm/sponge/condom with spermicide, vasectomy); female sexual partners of childbearing potential must be using and willing to continue using medically acceptable contraception (i.e., oral or transdermal hormonal contraceptives, vaginal ring, contraceptive implant or injection intrauterine contraceptive system \[with or without hormone\]) from Screening and for at least 90 days after the last study drug administration.
8. Must be able to speak, read, and understand English or Spanish sufficiently to allow completion of all study assessments.
9. Participant must be willing and able to follow study instructions and be likely to complete all study requirements.
Exclusion Criteria:
1. Participant has a history or presence of a clinically significant abnormality, as assessed by physical examination, medical history, electrocardiograms (ECGs; including a median QT interval corrected for heart rate \[Fridericia; QTcF interval\] of \>450 milliseconds if male or \>470 milliseconds if female at Screening and pre-operatively based on triplicate ECG; a repeat triplicate test is permitted and the median QTcF value will be used to determine eligibility), vital signs, or laboratory values, which, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. Laboratory tests may be repeated once (one time) at Screening only, after approval by the medical monitor, if the investigator determines that the abnormal laboratory finding(s) was erroneous or caused by a temporary medical condition, for example, an acute infection, or by the temporary use of a prior medication.
2. Participant has a significant cardiac (e.g., ischemia or infarct, complete bundle branch blocks, symptomatic arrhythmias or predominantly non-sinus-conducted rhythm), pulmonary, gastrointestinal, endocrine, metabolic (except diabetes mellitus \[A1c ≤7.0\]), neurological, or psychiatric disorder (resulting in disorientation, memory impairment or inability to report accurately; for instance, schizophrenia, Alzheimer's disease), or any other clinically significant disease that, in the investigator's opinion, may affect efficacy or safety assessments, or that may compromise participant safety during trial participation.
3. Participant has a history of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been treated and is no longer present.
4. Participant has a history or presence of acute respiratory depression, moderate or severe chronic pulmonary disease, cor pulmonale, delirium tremens, central nervous system (CNS) depression, or increased cerebrospinal or intracranial pressure.
5. Participant has a documented history of, or currently active, seizure disorder (excluding febrile seizures in childhood), or history of clinically significant head injury or syncope of unknown origin.
6. Participant has a current painful condition that could confound the interpretation of efficacy, safety, or tolerability data in the study, in the opinion of the investigator.
7. Participant has a history or presence of obstructive sleep apnea.
8. Participant has a known history of or presence of trypsin deficiency.
9. Participant has a history of acute or severe bronchial asthma, hypercarbia, or hypoxia.
10. Participant has any chronic gastrointestinal disease or major previous abdominal surgery (e.g., previous abdominoplasty surgery, Billroth procedure, enteroanastomosis, or bariatric surgery, including gastric bands and gastric sleeves, gastric bypass) that might affect the absorption, distribution, metabolism, or excretion of PF614. Prior cholecystectomy is allowed if the procedure was \>1 year prior to Screening. Prior Caesarean section is allowed if the participant does not have altered sensation to the scar area.
11. Participant has a history of pancreatitis, pancreatic insufficiency, gastric ulcers, or gastrointestinal bleeding.
12. Participant has evidence of clinically significant hepatic or renal impairment, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× the upper limit of normal (ULN), bilirubin \>2× ULN, estimated creatinine clearance \<60 mL/min (estimated by the 2021 Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] creatinine equation).
13. Participant has used chroni
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