Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery

Exclusion Criteria

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