Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers

Pacira

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: EXPAREL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02210247

402-C-113

Details and patient eligibility

About

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

Full description

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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 5 patient groups

Cohort 1

Active Comparator group

Description:

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

Treatment:

Drug: EXPAREL

Cohort 2

Active Comparator group

Description:

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.

Treatment:

Drug: EXPAREL

Cohort 3

Active Comparator group

Description:

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.

Treatment:

Drug: EXPAREL

Cohort 4

Active Comparator group

Description:

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.

Treatment:

Drug: EXPAREL

Cohort 5

Active Comparator group

Description:

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).

Treatment:

Drug: EXPAREL