Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT02210247

Run by

Pacira Pharmaceuticals, Inc

People needed

60

Starts

2014-08-01

Expected to finish

2014-09-01

Last updated by the study team

2021-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medpace Clinical Pharmacology Unit — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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