Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

Conditions
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Pain

Intervention / Treatment
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* Drug: EXPAREL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPAREL<br>Single administration of EXPAREL 133 mg (10 mL). | Drug: EXPAREL<br>* 133 mg EXPAREL in 10 mL.<br>* Other names: bupivacaine liposome injectable suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |