Dose-Escalation Study of HTX-034 Following Bunionectomy

Overview

This is a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b will evaluate escalating doses of HTX-034 compared with bupivacaine HCl. Optional 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.

Full Title of Study: “A Phase 1b/2, Randomized, Blinded, Active-Controlled Study of Escalating Doses of HTX-034 for Postoperative Analgesia in Subjects Undergoing Unilateral, First Metatarsal Bunionectomy With Osteotomy and Internal Fixation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2020

Interventions

  • Drug: HTX-034
    • HTX-034, Dose A
  • Drug: HTX-034
    • HTX-034, Dose B
  • Device: Luer lock applicator
    • Applicator for instillation
  • Drug: HTX-034
    • HTX-034, Dose C
  • Drug: Bupivacaine HCl
    • Bupivacaine HCl, 50 mg

Arms, Groups and Cohorts

  • Experimental: Phase 1b (Cohort 1)
    • Single dose level of HTX-034.
  • Experimental: Phase 1b (Cohort 2)
    • Individualized doses of HTX-034.
  • Experimental: Phase 2 (Optional)
    • Dose of HTX-034 selected from Phase 1b.
  • Active Comparator: Phase 1b and Phase 2
    • Bupivacaine HCl.

Clinical Trial Outcome Measures

Primary Measures

  • 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 the Day 8 Visit (Optional Phase 2)
    • Time Frame: 7 days

Secondary Measures

  • Maximum plasma concentration (Cmax) of HTX-034
    • Time Frame: 7 days
  • Time of maximum plasma concentration (Tmax) of HTX-034
    • Time Frame: 7 days
  • Area under the concentration-time curve from Time 0 to the time of the last quantitative concentration (AUClast) of HTX-034
    • Time Frame: 7 days
  • Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of HTX-034
    • Time Frame: 7 days
  • Apparent terminal half-life (t½) of HTX-034 (Phase 1B)
    • Time Frame: 7 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

Participating in This Clinical Trial

Inclusion Criteria

  • Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia).
  • Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
  • Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study; sterile, or using acceptable contraceptives.

Exclusion Criteria

  • Had contralateral foot bunionectomy in the past 3 months.
  • 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 a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
  • Has received or is taking a contraindicated or prohibited medications.
  • Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
  • 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.
  • Has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months.
  • Has a history of coronary artery bypass graft surgery within 12 months.
  • Has a history of known or suspected coagulopathy.
  • As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
  • 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 undergone 3 or more surgeries within 12 months.
  • Has a known history of glucose-6-phosphate dehydrogenase deficiency.
  • Has any of the following laboratory abnormalities during Screening (1 retest permitted):
  • Severe liver function impairment.
  • Severe kidney function impairment.
  • Platelet count <100,000/μL, hemoglobin <12 g/dL, or hematocrit <35%.
  • Has a body mass index (BMI) >39 kg/m2.

Gender Eligibility: All

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)
    • Chris Storgard, MD, (858) 251-4452, cstorgard@herontx.com

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