An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries

Overview

This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.

This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty. After a screening period, eligible patients will undergo study surgery under general anesthesia and have INL-001 implanted intraoperatively. Efficacy is also an exploratory measure in this study. The study includes a screening period, an inpatient period (preoperative, intraoperative, postoperative) of approximately 5 days, and an outpatient follow-up period (up to 30 days after treatment). Posttreatment safety and/or efficacy assessments will be made throughout the study and as specifically scheduled through 96 hours posttreatment, on day 7 (telephone), on day 15 (clinic visit), and on day 30 (clinic visit). Unless the investigator determines further hospitalization is necessary, patients will be discharged approximately 96 hours posttreatment (inpatient day 5). During the screening period, all patients will undergo eligibility and other screening and safety assessments. In addition, the investigator will administer the Pain Catastrophizing Scale (screening only) as an exploratory measure and the 15-item Quality of Recovery (QoR-15) questionnaire (baseline). Adverse event and concomitant medication information, including use of rescue pain medication, will be collected throughout the study (inpatient and outpatient). Surgical wound healing/grading assessments and assessment for signs and symptoms potentially indicative of systemic bupivacaine toxicity will be made. Blood samples for pharmacokinetic assessments will be collected from patients at multiple time points for the measurement of concentrations of bupivacaine in plasma. After surgery, patient reports of pain intensity using an 11-point numeric pain rating scale (NPRS) will be recorded at multiple time points through 96 hours posttreatment. Patients will be permitted rescue medication (oral and/or intravenous) to manage breakthrough pain when it occurs. The QoR-15 questionnaire and Patient Global Assessment (for pain control) will be administered on an inpatient basis and on day 7. The Opioid Related Symptom Distress Scale will be administered on an inpatient basis.