Phase 1
N=60
Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02210247 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Maximum Plasma Concentration (Cmax) — 129; 207; 202; 290 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- EXPAREL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pacira Pharmaceuticals, Inc
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
129; 207; 202; 290; 246 | — |
| PRIMARY Time to Maximum Concentration (Tmax) |
24; 48; 48; 36; 24 | — |
| PRIMARY Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration [AUC(0-last)] |
5917; 10976; 10201; 15227; 11567 | — |
| PRIMARY Apparent Terminal Elimination Half-life |
80.24; 44.88; 51.70; 33.22; 59.13 | — |
| PRIMARY The Apparent Terminal Elimination Rate Constant (λz) |
0.009; 0.019; 0.016; 0.021; 0.014 | — |
Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL via local subcutaneous infiltration in healthy volunteers.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02210247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.