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

• Sponsor: Cali Pharmaceuticals LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04182880
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 11.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Abdominoplasty	Drug: CPL-01; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jan 6, 2020
• Actual Primary Completion Date: Feb 28, 2020
• Actual Study Completion Date: Feb 28, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maximum (peak) plasma concentration (Cmax) [Baseline through 120 hours after start of study drug administration]

   Cmax

2. Time to reach highest observed (peak) concentration in plasma following IP administration (tmax) [Baseline through 120 hours after start of study drug administration]

   tmax

3. Area under the plasma concentration-time curve (AUC) from Time 0 to time of last quantifiable plasma concentration (AUC0-last) [Baseline through 120 hours after start of study drug administration]

   AUC0-last

4. AUC from Time 0 to infinity (AUC0-∞) [Baseline through 120 hours after start of study drug administration]

   AUC0-∞

5. elimination half-life [Baseline through 120 hours after start of study drug administration]

   t1/2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chesapeake Research Group	Pasadena	Maryland	United States	21122

Sponsors and Collaborators

• Cali Pharmaceuticals LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cali Pharmaceuticals LLC
• ClinicalTrials.gov Identifier: NCT04182880
• Other Study ID Numbers: CPL-01_AB_001
• First Posted: Dec 2, 2019
• Last Update Posted: Jun 9, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Jun 9, 2020