Trial Outcomes & Findings for Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain (NCT NCT04182880)

Last Updated: 2022-09-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Baseline through 120 hours after start of study drug administration

Results posted on

2022-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo Placebo: Placebo will be administered	CPL-01 CPL-01 CPL-01: CPL-01 will be administered
Overall Study STARTED	5	15
Overall Study COMPLETED	4	15
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo Placebo: Placebo will be administered	CPL-01 CPL-01 CPL-01: CPL-01 will be administered
Overall Study Pregnancy	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline through 120 hours after start of study drug administration

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Placebo Placebo: Placebo will be administered	CPL-01 n=15 Participants CPL-01 CPL-01: CPL-01 will be administered
Mean (Peak) Plasma Concentration (Cmax)	0 ng/mL Standard Deviation 0	573 ng/mL Standard Deviation 258

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 4 deaths

CPL-01

Serious events: 0 serious events

Other events: 11 other events

Deaths: 11 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=5 participants at risk Placebo Placebo: Placebo will be administered	CPL-01 n=15 participants at risk CPL-01 CPL-01: CPL-01 will be administered
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • 28 Days	20.0% 3/15 • Number of events 3 • 28 Days
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 1 • 28 Days	26.7% 4/15 • Number of events 4 • 28 Days
Gastrointestinal disorders Vomiting	20.0% 1/5 • Number of events 1 • 28 Days	0.00% 0/15 • 28 Days
General disorders Feeling Hot	20.0% 1/5 • Number of events 1 • 28 Days	6.7% 1/15 • Number of events 1 • 28 Days
Nervous system disorders Hypoaesthesia	40.0% 2/5 • Number of events 2 • 28 Days	6.7% 1/15 • Number of events 1 • 28 Days
Nervous system disorders Dizziness	20.0% 1/5 • Number of events 1 • 28 Days	6.7% 1/15 • Number of events 1 • 28 Days
Nervous system disorders Dysgeusia	20.0% 1/5 • Number of events 1 • 28 Days	6.7% 1/15 • Number of events 1 • 28 Days
Nervous system disorders Syncope	20.0% 1/5 • Number of events 1 • 28 Days	0.00% 0/15 • 28 Days
General disorders Malaise	20.0% 1/5 • Number of events 1 • 28 Days	0.00% 0/15 • 28 Days
Musculoskeletal and connective tissue disorders Back Pain	40.0% 2/5 • Number of events 2 • 28 Days	0.00% 0/15 • 28 Days
Infections and infestations Bacterial Vaginosis	20.0% 1/5 • Number of events 1 • 28 Days	0.00% 0/15 • 28 Days
Injury, poisoning and procedural complications Incision Site Rash	20.0% 1/5 • Number of events 1 • 28 Days	0.00% 0/15 • 28 Days

Additional Information

Chief Medical Officer

Cali Biosciences

Phone: 12038376500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=5 Participants Placebo Placebo: Placebo will be administered	CPL-01 n=15 Participants CPL-01 CPL-01: CPL-01 will be administered	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants