Dose-Escalation Study of HTX-034 Following Bunionectomy

NCT04398329 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: HTX-034-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 4

Brief Summary

This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 was a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b, compared with bupivacaine HCl.

Conditions

Bunions; Postoperative Pain

Keywords

Analgesia; Bunionectomy

Outcome Measures

Primary Outcomes (2)

• Incidence of TEAEs in Phases 1b/2

  The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.

  42 days

• AUC0-72 of Pain Scores

  Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) of pain intensity scores with activity (windowed worst observation carried forward) through 72 hours. The NRS was an 11-point scale (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.

  through 72 hours

Secondary Outcomes (9)

• Cmax for HTX-034

  29 days

• Tmax for HTX-034

  29 days

• AUClast for HTX-034

  29 days

• AUCinf for HTX-034

  22 days

• t½ of HTX-034

  22 days

Study Arms (5)

Phase 1b: HTX-034 Low Dose

EXPERIMENTAL

Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).

Drug: HTX-034 low dose; Device: Luer lock applicator

Phase 1b: HTX-034 High Dose

EXPERIMENTAL

Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).

Drug: HTX-034 high dose; Device: Luer lock applicator

Phase 2: HTX-034 Low Dose

EXPERIMENTAL

Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).

Drug: HTX-034 low dose; Device: Luer lock applicator

Phase 2: HTX-034 High Dose

EXPERIMENTAL

Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).

Drug: HTX-034 high dose; Device: Luer lock applicator

Phase 1b/2: Bupivacaine HCl

ACTIVE COMPARATOR

Bupivacaine HCl (without epinephrine) 0.5%: 50 mg

Drug: Bupivacaine HCl

Interventions

HTX-034 low dose DRUG

HTX-034 (bupivacaine/aprepitant/meloxicam) fixed dose: 21.7 mg/4.3 mg/0.6 mg

Phase 1b: HTX-034 Low Dose; Phase 2: HTX-034 Low Dose

HTX-034 high dose DRUG

HTX-034 (bupivacaine/aprepitant/meloxicam) individualized dose: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg

Phase 1b: HTX-034 High Dose; Phase 2: HTX-034 High Dose

Luer lock applicator DEVICE

Applicator for instillation

Phase 1b: HTX-034 High Dose; Phase 1b: HTX-034 Low Dose; Phase 2: HTX-034 High Dose; Phase 2: HTX-034 Low Dose

Bupivacaine HCl DRUG

Bupivacaine HCl 50 mg

Phase 1b/2: Bupivacaine HCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (4)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78229, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84017, United States

Location

MeSH Terms

Conditions

Bunion; Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Tricia Mulford
• Organization: Heron Therapeutics, Inc.

tmulford@herontx.com

760-622-3709

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: May 8, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: June 9, 2026
• Results First Posted: June 9, 2026

Record last verified: 2026-06

Locations

US (4)