Trial Outcomes & Findings for Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy (NCT NCT02199574)

NCT ID: NCT02199574

Last Updated: 2021-03-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: From time of study drug administration through Day 7 postdose
• Results posted on: 2021-03-08

Participant Flow

Participant milestones

Measure	EXPAREL Single administration of EXPAREL 133 mg (10 mL). EXPAREL
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

Baseline characteristics by cohort

Measure	EXPAREL n=12 Participants Single administration of EXPAREL 133 mg (10 mL). EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35.6 years STANDARD_DEVIATION 13.30 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: From time of study drug administration through Day 7 postdose

Outcome measures

Measure	EXPAREL n=11 Participants Single administration of EXPAREL 133 mg (10 mL). EXPAREL: 133 mg EXPAREL in 10 mL.
Maximum Plasma Concentration (Cmax)	254 ng/mL Standard Deviation 82.6

PRIMARY outcome

Timeframe: From time of study drug administration through Day 7 postdose

Outcome measures

Measure	EXPAREL n=11 Participants Single administration of EXPAREL 133 mg (10 mL). EXPAREL: 133 mg EXPAREL in 10 mL.
Time to Maximum Plasma Concentration (Tmax)	0.50 hours Interval 0.22 to 35.7

PRIMARY outcome

Timeframe: From time of study drug administration through Day 7 postdose

Outcome measures

Measure	EXPAREL n=11 Participants Single administration of EXPAREL 133 mg (10 mL). EXPAREL: 133 mg EXPAREL in 10 mL.
Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))	7150 hours*ng/mL Standard Deviation 3189

PRIMARY outcome

Timeframe: From time of study drug administration through Day 7 postdose

Outcome measures

Measure	EXPAREL n=3 Participants Single administration of EXPAREL 133 mg (10 mL). EXPAREL: 133 mg EXPAREL in 10 mL.
Apparent Terminal Elimination Half-life	9.34 hours Standard Deviation 2.31

PRIMARY outcome

Timeframe: From time of study drug administration through Day 7 postdose

Outcome measures

Measure	EXPAREL n=3 Participants Single administration of EXPAREL 133 mg (10 mL). EXPAREL: 133 mg EXPAREL in 10 mL.
Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))	6379 hours*ng/mL Standard Deviation 2825

PRIMARY outcome

Timeframe: From time of study drug administration through Day 7 postdose

Outcome measures

Measure	EXPAREL n=3 Participants Single administration of EXPAREL 133 mg (10 mL). EXPAREL: 133 mg EXPAREL in 10 mL.
The Apparent Terminal Elimination Rate Constant (λz)	0.07779 1/hours Standard Deviation 0.02222

Adverse Events

EXPAREL

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	EXPAREL n=12 participants at risk Single administration of EXPAREL 133 mg (10 mL). EXPAREL
General disorders pyrexia	8.3% 1/12 • Number of events 1
Skin and subcutaneous tissue disorders rash	8.3% 1/12 • Number of events 1

Additional Information

Pacira Medical Information

Pacira Pharmaceuticals, Inc.

Phone: 1-855-793-9727

Email: MedInfo@pacira.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place