7. The participant has adequate hepatic function [bilirubin ≤ 1.5 times the upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 3.0 times ULN, or ≤ 5.0 times ULN if the transaminase elevation is due to liver metastases]