Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy

Exclusion Criteria

• •The subject will be excluded from participating in the trial if the subject:
• •Has a history of clinically significant medical condition that based upon the judgment of the investigator makes participation inappropriate
• •Has a history of a major bleeding event (defined as: (i) symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or (ii) a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells) within 6 months prior to screening visit
• •Has had major surgery within 6 months prior to screening visit
• •Is actively taking any the following list of medications/supplements and cannot hold these medications for \<5 half-lives prior to the study:
• •CYP3A4 Moderate/Strong Inhibitors:
• •Selective Serotonin Reuptake Inhibitors (SSRI) Amiodarone, Dronedarone Diltiazem Cimetidine Aprepitant Protease Inhibitors CYP3A4 Inducers Rifampin Phenytoin Carbemazepine Ritonavir St. John's Wort Enzalutamide Efavirenz Teriflunomide Bosentan Modafinil Mitotane Other Pancreatic Enzyme Replacement (Creon, Pancrelipase, Viokase)
• •Has a history of illicit drug abuse within six months prior to screening visit
• •Is an active smoker (last exposure \<2 weeks prior to study screening)
• •Pregnant or lactating
• •Consumes greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[354 mL/12 ounces\], wine \[118 mL/4 ounces\], or distilled spirits \[29.5 mL/1 ounce\]) per day and cannot refrain from alcohol for the duration of the trial
• •Has a history of significant multiple and/or severe allergies (e.g. food, drug), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
• •Has known anaphylactic or severe systemic reactions to any components of apixaban or contraindication to the administration of apixaban
• •Has moderate or severe hepatic disease or other clinically relevant bleeding risk
• •Use of any drugs or products which at the discretion of the investigator would increase bleeding risk
• •Is considered inappropriate for participation by the investigator for any reason