HTX-011 Administration Study in Planned Caesarean Section Procedure

Overview

This is a Phase 2, open-label study to evaluate the PK and safety of HTX-011 in women undergoing a planned C-section.

Full Title of Study: “A Phase 2 Open-Label Study of the Pharmacokinetics (PK) and Safety of HTX-011 Administered Postpartum to Women Undergoing a Planned Caesarean Section”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2021

Interventions

  • Drug: HTX-011
    • 300 mg
  • Drug: HTX-011
    • 400 mg
  • Device: Luer Lock Applicator
    • Applicator for instillation.
  • Drug: Ibuprofen
    • 400 mg
  • Drug: Acetaminophen
    • 975 mg to 1 g

Arms, Groups and Cohorts

  • Experimental: Treatment Group 1
    • A single dose of HTX-011 administered via instillation into the surgical site.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heron Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Erol Onel, MD, (858) 251-4420, HTX011-ct@herontx.com

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