12. Subject has any of the following laboratory test results at cycle 1 day 1 pre-dosing: 1) Alanine aminotransferase level (ALT) >/= 2.5 x the upper limit of normal (ULN); 2) Aspartate Aminotransferase (AST) >/= 2.5 x the ULN; 3) Total bilirubin level >/= 1.5 x ULN, (except for Gilbert Syndrome: direct bilirubin >/= 1.5 x ULN); 4) Creatinine > 2 x ULN.