This is a Phase 2, open-label study to evaluate the PK and safety of HTX-011 in women undergoing a planned C-section.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Helen Keller Hospital
Sheffield, Alabama, United States
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States
Duke University Medical Center
Durham, North Carolina, United States
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Maximum plasma concentration (Cmax) of bupivacaine, meloxicam, dimethyl sulfoxide (DMSO) and HTX-011 polymer
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Time of maximum plasma concentration (Tmax) of bupivacaine, meloxicam, DMSO and HTX-011 polymer
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Half life (t1/2) in plasma of bupivacaine, meloxicam, DMSO and HTX-011 polymer
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Half life (t1/2) in milk of bupivacaine, meloxicam, DMSO and HTX-011 polymer
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Amount of analyte excreted in breast milk over time (Ae)
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Fraction of dose excreted in breast milk over time (Fe)
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Mean area under the curve of the NRS pain scores through 72 hours (AUC0-72).
Time frame: 72 hours
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: 28 Days.
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400 mg
975 mg to 1 g