 9. Preserved major organ functions, i.e: Blood leukocyte count 3.0 x 109L Blood absolute neutrophil count 1.5 x 109L Blood platelet count 100 x109L Blood hemoglobin 100 gL transfusions are allowed Plasma total bilirubin level 1.5 times the upper institutional limit ULN of the normal i.e. reference range Plasma AST aspartate aminotransferase or ALT 2.5 times upper institutional limit ULN of the normal range Plasma creatinine 1.5 times upper institutional limit ULN of the normal range 12-lead ECG with normal tracings; or changes that are not clinically significant and do not require medical intervention, and QTc 500 ms At least seven 7 days off of medications which inhibit or induce CYP2C9 or CYP3A4 before first study treatment day 