Abdominoplasty
Conditions
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.
Interventions
DRUGCPL-01
CPL-01 will be administered
DRUGPlacebo
Placebo will be administered
Sponsors
Cali Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean (Peak) Plasma Concentration (Cmax) | Baseline through 120 hours after start of study drug administration | 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. |
Countries
United States
Contacts
STUDY_CHAIRErol Onel, MD
Cali Biosciences
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo
Placebo: Placebo will be administered | 5 |
| CPL-01 CPL-01
CPL-01: CPL-01 will be administered | 15 |
| Total | 20 |
Baseline characteristics
| Characteristic | Placebo | CPL-01 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 15 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 15 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 13 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 5 Participants | 15 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 5 | 11 / 15 |
| other Total, other adverse events | 4 / 5 | 11 / 15 |
| serious Total, serious adverse events | 0 / 5 | 0 / 15 |
Outcome results
Primary
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.
Time frame: Baseline through 120 hours after start of study drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean (Peak) Plasma Concentration (Cmax) | 0 ng/mL | Standard Deviation 0 |
| CPL-01 | Mean (Peak) Plasma Concentration (Cmax) | 573 ng/mL | Standard Deviation 258 |