Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-09-30

Brief Summary

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The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL via local subcutaneous infiltration in healthy volunteers.

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Detailed Description

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During Dosing Period 1, blood samples for pharmacokinetic (PK) analysis will be obtained predose (15 minutes prior to administration of EXPAREL) through 12 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, and 12 hours) for Cohort 4; through 36 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, and 36 hours) for Cohort 3; through 60 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, and 60 hours) for Cohort 2; and through 72 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours) for Cohorts 1 and 5.

During Dosing Period 2 (Cohorts 2, 3, and 4 only), blood samples for PK analysis will be obtained predose (15 minutes prior to administration of EXPAREL) through 72 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours).

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Cohort 1 will receive a single dose of EXPAREL 266 mg on Day 1. No additional dose will be given.

Group Type ACTIVE_COMPARATOR

EXPAREL

Intervention Type DRUG

Cohort 2

Cohort 2 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours.

Group Type ACTIVE_COMPARATOR

EXPAREL

Intervention Type DRUG

Cohort 3

Cohort 3 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours.

Group Type ACTIVE_COMPARATOR

EXPAREL

Intervention Type DRUG

Cohort 4

Cohort 4 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours.

Group Type ACTIVE_COMPARATOR

EXPAREL

Intervention Type DRUG

Cohort 5

Cohort 5 will receive a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL).

Group Type ACTIVE_COMPARATOR

EXPAREL

Intervention Type DRUG

Interventions

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EXPAREL

Intervention Type DRUG

Other Intervention Names

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bupivacaine liposome injectable suspension

Eligibility Criteria

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Inclusion Criteria

* Males or females ≥18 years of age.
* American Society of Anesthesiologists (ASA) physical status 1 or 2.
* Female subjects must be surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before the first study drug administration.
* Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria

* History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
* History of abnormal bleeding tendencies/clotting disorders.
* Regular use of anticoagulants (except for low dose aspirin for cardioprotection).
* Received any investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure during his/her participation in this study.
* Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
* Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
* Received bupivacaine or other local anesthetic within 7 days of first study drug administration.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes