Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02199574

Enrollment

Registered

2014-07-24

Start date

2014-08-31

Completion date

2015-06-30

Last updated

2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of the adenoids.

Detailed description

Blood samples for bupivacaine PK analysis will be obtained from subjects at baseline (within 30 minutes prior to EXPAREL infiltration), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 36, 48, and 72 hours after the beginning of EXPAREL infiltration, and on Day 7.

Interventions

DRUGEXPAREL

133 mg EXPAREL in 10 mL.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female, ≥18 years of age at the Screening Visit. * Subjects undergoing tonsillectomy with or without removal of the adenoids. * Able and willing to comply with all study visits and procedures. * Willing and capable of providing written informed consent.

Exclusion criteria

* History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics. * Received any investigational drug within 30 days prior to EXPAREL administration, and/or has planned administration of another investigational product or procedure while participating in this study. * Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after EXPAREL administration. Female subjects must be surgically sterile, at least 2 years postmenopausal, or using an acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before EXPAREL administration. * Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to EXPAREL and/or procedures, or cause inability to comply with the study requirements.

Design outcomes

Primary

Measure	Time frame
Maximum Plasma Concentration (Cmax)	From time of study drug administration through Day 7 postdose
Time to Maximum Plasma Concentration (Tmax)	From time of study drug administration through Day 7 postdose
Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))	From time of study drug administration through Day 7 postdose
Apparent Terminal Elimination Half-life	From time of study drug administration through Day 7 postdose
Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))	From time of study drug administration through Day 7 postdose
The Apparent Terminal Elimination Rate Constant (λz)	From time of study drug administration through Day 7 postdose

Countries

United States

Participant flow

Participants by arm

Arm	Count
EXPAREL 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.	12
Total	12

Baseline characteristics

Characteristic	EXPAREL
Age, Categorical <=18 years	1 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	11 Participants
Age, Continuous	35.6 years STANDARD_DEVIATION 13.3
Region of Enrollment United States	12 participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	2 / 12
serious Total, serious adverse events	0 / 12