- Hepatic Function: Bilirubin must not be more than 1.5 x ULN (does not apply to patients with Gilbert s Disease) and the AST and ALT must not be more than 2.5 x ULN within 72 hours prior to enrollment, or greater than 5.0 X ULN if in the Investigator s judgment it is related to liver metastases. AST and ALT may be up to 5 x ULN within 72 hours prior to enrollment in participants with hepatic metastases.