- Hepatic function and enzymes: AST and ALT <= 2.5 x the upper normal limit (ULN) of institution's normal range; Bilirubin <= 1.5 x ULN. Subjects with Gilbert's Syndrome may have a Bilirubin > 1.5 x ULN; Subjects with liver metastasis may have an AST and ALT of <= 5.0 x ULN;