Post-Operative Pain and Opioid Reduction Trial After Bunionectomy

Study Overview
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Brief Summary
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This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.

Detailed Description
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Near the completion of surgery, a single dose of study drug (CPL-01, saline placebo, or ropivacaine HCl) will be infiltrated. Subjects will remain in the hospital/research facility for a minimum of 72 hours after the start of study drug administration to undergo postoperative assessments. Subjects will return to the study site on Day 7 to complete follow up assessments, on Day 28 for follow-up assessments including an X-Ray, and on Day 42 for the end-of-study (EOS) visit.

Official Title
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Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate Safety, Efficacy, and PK of CPL-01 in Post-Op Pain After Unilateral Distal First Metatarsal Bunionectomy + Osteotomy

Conditions
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Hallux Valgus and Bunion

Intervention / Treatment
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* Drug: Analgesic Non Narcotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be willing and able to sign the informed consent form (ICF) prior to study participation In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and ASA Class I or II at the time of randomization Plan to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries Have a BMI ≤ 39 kg/m2 Exclusion Criteria: Previous unilateral simple bunionectomy Has a planned concurrent surgical procedure that may impact pain scores, rescue medication use, or ability to fulfill the requirements of the protocol Concurrent painful condition Active skin disease or other clinically significant abnormality at the anticipated surgical site that could interfere with the planned surgery Known hypersensitivity or known allergy, as determined by the Investigator, to the ingredients (i.e., excipients) of the study drug or any peri- or postoperative medications used in this study History or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency History or evidence of impaired liver function (e.g., ALT > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis History or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN) History of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix Has or has had active COVID-19 infection within 3 months prior to surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Bunion Surgery
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPL-01<br>Low dose of CPL-01 | Drug: Analgesic Non Narcotic<br>* Injection of protocol-specified volume of local analgesic<br>* Other names: Infiltration of local analgesic;|
| Active Comparator: Ropivacaine HCl<br>Low dose of Ropivacaine HCl | Drug: Analgesic Non Narcotic<br>* Injection of protocol-specified volume of local analgesic<br>* Other names: Infiltration of local analgesic;|
| Placebo Comparator: Placebo<br>Low volume of placebo | Drug: Analgesic Non Narcotic<br>* Injection of protocol-specified volume of local analgesic<br>* Other names: Infiltration of local analgesic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC72 | Pain score through 72 hours post-operative | 72 hours post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use (MME) | Opioid use through 72 hours post-operative | 72 hours post-operative |