HTX-011 Administration Study in Planned Caesarean Section Procedure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Group 1 A single dose of HTX-011 administered via instillation into the surgical site. |
Drug: HTX-011
300 mg
Other Names:
Device: Luer Lock Applicator
Applicator for instillation.
|
| Experimental: Treatment Group 2 A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen. |
Drug: HTX-011
400 mg
Other Names:
Device: Luer Lock Applicator
Applicator for instillation.
Drug: Ibuprofen
400 mg
Drug: Acetaminophen
975 mg to 1 g
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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.]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helen Keller Hospital | Sheffield | Alabama | United States | 35660 |
| 2 | Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | United States | 92123 |
| 3 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 4 | UPMC Magee-Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Heron Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HTX-011-220