Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation

NCT04293809 | Completed Phase 1 FDA Drug

• 1 other identifier: 402-C-123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block. A total of 15 subjects will be enrolled in each of the 2 cohorts.

Conditions

Breast Augmentation

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetic 1 (area under the plasma concentration)

  Area under the plasma concentration-versus-time curve (AUC)

  predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration

• Pharmacokinetic 2 (Cmax)

  Maximum plasma concentration

  predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration

• Pharmacokinetic 3 (half-life)

  The apparent terminal elimination half-life (t1/2el)

  predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration

• Pharmacokinetic 4 (apparent clearance)

  Apparent Clearance (CL/F)

  predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration

• Pharmacokinetic 5 (Mean residence time)

  Mean residence time (MRT)

  predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration

Study Arms (2)

Cohort 1 - EXPAREL

EXPERIMENTAL

A total of 15 subjects will be enrolled in this cohort. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of saline

Drug: Exparel Injectable Product

Cohort 2 - EXPAREL

EXPERIMENTAL

A total of 15 subjects will be enrolled. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of 0.5% bupivacaine HCl (150mg)

Drug: Exparel Injectable Product; Drug: Bupivacaine Hydrochloride

Interventions

Exparel Injectable Product DRUG

bupivacaine liposome injectable suspension

Cohort 1 - EXPAREL; Cohort 2 - EXPAREL

Bupivacaine Hydrochloride DRUG

1.3%, 13.3 mg/mL

Cohort 2 - EXPAREL

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 or older, undergoing breast augmentation and are American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
• Able to provide informed consent, adhere to the study schedule, and complete all study assessments
• Body Mass Index ≥18 and ≤30 kg/m2

You may not qualify if:

• Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
• Documented history of long-term diabetes (≥10 years) or severe peripheral vascular disease
• Renal (serum creatinine level \>2mg/dL \[176.8 μmol/L\]) or hepatic dysfunction (serum alanine or aspartame transferase \> 3 times the upper limit of normal)
• Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
• Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
• Previous participation in an EXPAREL study
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
• Currently pregnant, nursing, or planning to become pregnant during the study
• Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
• Currently on neuroleptic agent \[e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.\]
• Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

HD Research

Bellaire, Texas, 77401, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nayana Nagaraj, MD, PhD, MPH

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 3, 2020
• Study Start: December 19, 2019
• Primary Completion: January 15, 2020
• Study Completion: January 29, 2020
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)