Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery

Inclusion criteria

• Has signed the trial-specific informed consent form.
• Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized, e.g. tubal ligation, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
• Patients undergoing CABG, valve(s), CABG/valve(s) and/or aortic root or ascending aortic aneurysm repair surgery.
• Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
• EF ≥ 30%, evaluated within 2 months prior to screening visit.

Exclusion criteria

• Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
• Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
• Confirmed or suspected endocarditis.
• Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
• Receiving Aprotinin during the trial, from Screening to Day 90.
• Having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery.
• Active peptic ulcer disease and gastritis.
• Hemoccult positive stools, hematological, bleeding, and coagulation disorders.
• Receiving dopamine at renal doses (2-4 mcg/kg/min), from Screening to Day of surgery.
• S-Creatinine greater than 2.1 mg/dl.
• Known or suspected hypersensitivity to the investigational medicinal product.
• Known or suspected hypersensitivity to Ondansetron or other selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonists.
• Current participation in any other interventional clinical trial.
• Previously dosed with AP214.
• Use of investigational medicinal products within the previous 6 months.
• Body weight above 140 kg.
• History of any organ transplant.
• Women who are of childbearing potential, pregnant, or breast-feeding.
• Current abuse of alcohol or substance, according to the investigator's medical judgment.
• Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
• Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.