AbdominoplastyPhase 2NCT04182880
Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain
A Phase 2 study testing CPL-01 in people with Abdominoplasty, run by Cali Pharmaceuticals LLC at 1 site in United States.
Trial summary
Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in patients after mini-abdominoplasty Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty
- What is being tested?
- CPL-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 28 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Not pregnant
- Not breastfeeding
Show all 10Show fewer
- Not planning to become pregnant during participation in the study
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in patients after mini-abdominoplasty
Read the 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
- Being tested
- CPL-01, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPL-01Drug
CPL-01 will be administered
PlaceboDrug
Placebo will be administered
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| CPL-01 | Experimental | CPL-01 Receives: Drug: CPL-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 120 hours after start of study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start6 Jan 2020
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AbdominoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cali Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erol Onel, MD, Study chair, Cali Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182880
- Sponsor's protocol ID
- CPL-01_AB_001
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2019
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pope S, Crean C, Thrasher S, Xu H, Chen PJ, Chen L, Hu D, Onel E. Comparison of Pharmacokinetics of Long-Acting Local Analgesics: CPL-01, a Novel Extended-Release Ropivacaine, Demonstrates Consistent and Predictable Exposure Compared with Liposomal Bupivacaine. Clin Drug Investig. 2025 Feb;45(2):51-58. doi: 10.1007/s40261-025-01419-w. Epub 2025 Jan 29.
PubMed 39881115
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04182880
- Acronym / sponsor ID
- CPL-01_AB_001
- Conditions
- Abdominoplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cali Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| CPL-01 | Experimental | Drug: CPL-01CPL-01 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPL-01CPL-01 will be administered | Drug | CPL-01 |
| PlaceboPlacebo will be administered | Drug | Placebo |
Primary outcome
Mean (Peak) Plasma Concentration (Cmax)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39881115Pope S, Crean C, Thrasher S, Xu H, Chen PJ, Chen L, Hu D, Onel E. Comparison of Pharmacokinetics of Long-Acting Local Analgesics: CPL-01, a Novel Extended-Release Ropivacaine, Demonstrates Consistent and Predictable Exposure Compared with Liposomal Bupivacaine. Clin Drug Investig. 2025 Feb;45(2):51-58. doi: 10.1007/s40261-025-01419-w. Epub 2025 Jan 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erol Onel, MD study chair
Cali Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPL-01 in people with Abdominoplasty, run by Cali Pharmaceuticals LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean (Peak) Plasma Concentration (Cmax) (time frame: Baseline through 120 hours after start of study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04182880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.