- Subject must have adequate renal, hepatic and coagulation function per local laboratory reference range as follows: Serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance ≥ 50 mL/min; AST and ALT ≤ 3.0 × the upper normal limit (ULN); Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's Syndrome may have a Bilirubin > 1.5 × ULN; aPTT, PT not to exceed 1.2 × ULN