Analgesia
Conditions
Keywords
postoperative pain, caesarean section, C-section
Brief summary
This is a Phase 2, open-label study to evaluate the PK and safety of HTX-011 in women undergoing a planned C-section.
Interventions
DRUGHTX-011
300 mg
DEVICELuer Lock Applicator
Applicator for instillation.
DRUGIbuprofen
400 mg
DRUGAcetaminophen
975 mg to 1 g
Sponsors
Heron Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is expected, at the time of Screening visit, to deliver a single neonate. * Is scheduled to undergo a planned C-section surgery with a low transverse skin incision (eg, Pfannenstiel). * Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III. * Agrees to practice abstinence or use double-barrier contraception in the event of sexual activity and commits to the use of an acceptable form of birth control for 30 days after HTX-011 administration. * Agrees to refrain from the use of breast milk from this pregnancy in any manner.
Exclusion criteria
* Has planned to breastfeed her neonate at any time during the 28-day period after HTX-011 administration. * Has had a prior full-term pregnancy with unsuccessful breast milk expression. * Has a planned concurrent surgical procedure. * Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * Has been administered bupivacaine within 5 days prior to the scheduled surgery. * Has been administered any local anesthetic within 72 hours prior to the scheduled surgery. * Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. * Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control. * Has taken any NSAIDs within least 10 days prior to the scheduled surgery. * Has current significant placental abnormality/complications including, but not limited to, placenta previa or placenta accreta. * Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. * Has uncontrolled anxiety, psychiatric, or neurological disorder. * Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. * Previously participated in an HTX-011 study. * Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives. * Weight is \<50 kg at the time of Screening visit. * In the Investigator's judgment, subject is likely to have been morbidly obese prior to her pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs). | 28 Days. |
| Mean area under the curve of the NRS pain scores through 72 hours (AUC0-72). | 72 hours |
Countries
United States
Outcome results
None listed