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

NCT ID: NCT04182880

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2020-02-28

Brief Summary

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

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.

Conditions

Abdominoplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered

CPL-01

CPL-01

Group Type: EXPERIMENTAL

CPL-01

Intervention Type: DRUG

CPL-01 will be administered

Interventions

CPL-01

CPL-01 will be administered

Intervention Type: DRUG

Placebo

Placebo will be administered

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cali Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erol Onel, MD

Role: STUDY_CHAIR

Cali Biosciences

Locations

Chesapeake Research Group

Pasadena, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CPL-01_AB_001

Identifier Type: -

Identifier Source: org_study_id