Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates

Exclusion Criteria

• •Confirmed CYP2C8, CYP2C9, or CYP2C19 poor metabolizer status based on genotyping analysis;
• •Absolute neutrophil count \< 1,500/μL, platelet count \< 100,000/μL, and hemoglobin \< 5.6 mmol/L (9 g/dL) during the screening period (NOTE: patients may not have received any growth factors or blood transfusions within 7 days prior to the hematologic laboratory values obtained during the screening period);
• •Total bilirubin \> 1.5 times, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of normal during the screening period;
• •Creatinine \> 177 μmol/L (2 mg/dL) during the screening period;
• •Albumin \< 30 g/L (3.0 g/dL) during the screening period;
• •Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide), 5 α reductase inhibitors (finasteride, dutasteride), estrogens, or chemotherapy within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments during the study;
• •Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments during the study;
• •Structurally unstable bone lesions suggesting impending fracture;
• •History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months prior to enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization)