- In good health as determined by medical history, physical examination including height and weight, and clinical safety laboratory examinations. For creatinine and alkaline phosphatase levels the applicable cut-offs for determination are the upper limits of normal only, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values. For aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the applicable cut-offs for determination are less than 1.5 times the upper limits of normal, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values or with mild elevations above the upper limits of normal.