Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN)Total bilirubin ≤ 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome. Adequate renal function, defined by calculated serum creatinine clearance (CrCl) ≥ 30 mL/min