Dose-Escalation Study of HTX-034 Following Bunionectomy

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.