This is a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b will evaluate escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 will be a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b compared with bupivacaine HCl.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
73
HTX-034, low dose
HTX-034, high dose
Applicator for instillation
Arizona Research Center
Phoenix, Arizona, United States
First Surgical Hospital
Bellaire, Texas, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Incidence of Treatment-emergent adverse events (TEAE's) (Phase 1B)
Time frame: 42 days
Mean area under the curve (AUC) of the NRS scores through 72 hours (AUC0-72) for the pooled Phase 1b and Phase 2
Time frame: 7 days
Maximum plasma concentration (Cmax) of HTX-034
Time frame: 29 days
Time of maximum plasma concentration (Tmax) of HTX-034
Time frame: 29 days
Area under the concentration-time curve from Time 0 to the time of the last quantitative concentration (AUClast) of HTX-034
Time frame: 29 days
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of HTX-034 (Phase 1B)
Time frame: 22 days
Apparent terminal half-life (t½) of HTX-034 (Phase 1B)
Time frame: 22 days
Mean AUC of the NRS pain intensity scores
Time frame: 7 days
Total postoperative opioid consumption (in IV Morphine Milligram Equivalents)
Time frame: 7 days
Proportion of subjects who are opioid-free
Time frame: 14 days
Incidence of serious adverse Events (SAE's)
Time frame: 42 days
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Bupivacaine HCl, 50 mg