Dose-Escalation Study of HTX-034 Following Bunionectomy

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.