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This is a Phase 2, open-label study to evaluate the PK and safety of HTX-011 in women undergoing a planned C-section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | A single dose of HTX-011 administered via instillation into the surgical site. |
|
| Treatment Group 2 | Experimental | A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTX-011 | Drug | 300 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of bupivacaine, meloxicam, dimethyl sulfoxide (DMSO) and HTX-011 polymer | 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 | 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 | 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 | 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) | 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) | Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean area under the curve of the NRS pain scores through 72 hours (AUC0-72). | 72 hours | |
| Incidence of treatment-emergent adverse events (TEAEs). | 28 Days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Keller Hospital | Sheffield | Alabama | 35660 | United States | ||
| Sharp Mary Birch Hospital for Women and Newborns |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C423142 | KPNA1 protein, human |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| HTX-011 |
| Drug |
400 mg |
|
|
| Luer Lock Applicator | Device | Applicator for instillation. |
|
| Ibuprofen | Drug | 400 mg |
|
| Acetaminophen | Drug | 975 mg to 1 g |
|
| San Diego |
| California |
| 92123 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| UPMC Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |