 4. Patients must have adequate renal and hepatic function: -- Serum bilirubin 1.5 x upper limit of normal ULN. For patients with Gilberts disease, serum bilirubin up to 3 x ULN is allowed provided normal direct bilirubin, -- Serum creatinine 1.5 x ULN, -- ALT and AST 3 x ULN. 