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

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

Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in patients after mini-abdominoplasty

Study Overview

• Status: Completed
• Conditions: Abdominoplasty
• Intervention / Treatment: Drug: Placebo; Drug: CPL-01

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Pasadena, Maryland, United States, 21122
      • Chesapeake Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  1. Not pregnant
  2. Not breastfeeding
  3. Not planning to become pregnant during participation in the study
  4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo will be administered
Experimental: CPL-01	Drug: CPL-01; CPL-01 will be administered

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cali Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CPL-01_AB_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No