Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain

Study Overview
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Brief Summary
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Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in patients after mini-abdominoplasty

Detailed Description
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This is a randomized, double-blind, study to evaluate the safety, PK profile of CPL-01 for the management of postoperative pain after mini-abdominoplasty surgery.

Official Title
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Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain After Mini-abdominoplasty Surgery

Conditions
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Abdominoplasty

Intervention / Treatment
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* Drug: CPL-01
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject provides signed, written informed consent before participation in the study. Subject is aged ≥18 and ≤70 years at the time of informed consent and is male or female. Subject is scheduled to undergo elective mini-abdominoplasty surgery under general anesthesia without collateral procedures. Female subjects are eligible only if all the following apply: Not pregnant Not breastfeeding Not planning to become pregnant during participation in the study Committed to the use of an acceptable form of birth control for the duration of the study until at least 30 days after administration of IP. Male subjects must commit to the use of a reliable method of birth control for the duration of the study until at least 30 days after administration of IP or be surgically sterile (biologically or surgically). Subject is free of any physical, mental, or medical conditions which, in the opinion of the investigator, make mini-abdominoplasty or study participation inadvisable. Exclusion Criteria: Subject has known, suspected, or reported history of alcohol or drug abuse or dependence within the previous 2 years as assessed by the investigator Subject has impaired liver function (e.g., aspartate aminotransferase/alanine aminotransferase greater than 3 times the upper limit of the reference range, bilirubin greater than 1.5 times the upper limit of the reference range unless due to Gilbert's syndrome, active hepatic disease, evidence of clinically significant liver disease, or other condition such as alcoholism, cirrhosis, or hepatitis, etc.) that suggests the potential for an increased susceptibility to hepatic toxicity with IP exposure. Subject has clinically significant renal abnormalities (creatinine ≥1.5 × upper limit of normal). Subject has hemoglobin A1c ≥7.0%. Subject has participated in another clinical study and/or received an IP (marketed or premarket) within 30 days before surgery. Subject has a history of, or positive test results for, human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody at Screening. Subject with an upper respiratory infection/cough in the 14 days before surgery. Subjects with a history of significant postoperative nausea and vomiting.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo will be administered<br>|
| Experimental: CPL-01<br>CPL-01 | Drug: CPL-01<br>* CPL-01 will be administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean (Peak) Plasma Concentration (Cmax) | Mean Cmax of 573 ng/mL and occurred at approximately 13 hours. Timepoints tested included before study drug administration and 15, 30, and 45 minutes and 1, 2, 4, 6, 8, 10, 12, 18, 24, 30, 36, 48, 60, 72, 96, and 120 hours after administration. | Baseline through 120 hours after start of study drug administration |