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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2020

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.

Interventions

  • Drug: CPL-01
    • CPL-01 will be administered
  • Drug: Placebo
    • Placebo will be administered

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Placebo
  • Experimental: CPL-01
    • CPL-01

Clinical Trial Outcome Measures

Primary Measures

  • Maximum (peak) plasma concentration (Cmax)
    • Time Frame: Baseline through 120 hours after start of study drug administration
    • Cmax
  • Time to reach highest observed (peak) concentration in plasma following IP administration (tmax)
    • Time Frame: Baseline through 120 hours after start of study drug administration
    • tmax
  • Area under the plasma concentration-time curve (AUC) from Time 0 to time of last quantifiable plasma concentration (AUC0-last)
    • Time Frame: Baseline through 120 hours after start of study drug administration
    • AUC0-last
  • AUC from Time 0 to infinity (AUC0-∞)
    • Time Frame: Baseline through 120 hours after start of study drug administration
    • AUC0-∞
  • elimination half-life
    • Time Frame: Baseline through 120 hours after start of study drug administration
    • t1/2

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cali Pharmaceuticals LLC
  • Provider of Information About this Clinical Study
    • Sponsor

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