A QT/QTc and Multi-Dose Pharmacokinetic Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * Documented metastatic disease * Has not received chemotherapy or has no more than one line of cytotoxic chemotherapy or biologic therapy for treatment of castration resistant prostate cancer (CRPC) * Documented prostate specific antigen (PSA) progression as assessed by the investigator according to Prostate Cancer Working Group 2 (PCWG2) criteria despite medical or surgical castration, or prostate cancer progression documented by radiographic progression according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria * Surgically or medically castrated with testosterone levels of \<50 ng/dL (\<2.0 nM) * Eastern Cooperative Oncology Group (ECOG) Performance Status of \<= 1 * Agrees to protocol-defined use of effective contraception * Protocol-specified laboratory parameters Exclusion Criteria: * Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * Abnormal liver function * Uncontrolled hypertension * Active or symptomatic viral hepatitis or chronic liver disease * Known brain metastasis * History of pituitary or adrenal dysfunction * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50 % at baseline * Diagnosis of cardiac arrhythmia * Treatment with anti-arrhythmic drugs primarily for cardiac arrhythmia * Abnormal electrocardiogram * Other malignancy (except non-melanoma skin cancer, that is active or has a ≥ 30% probability of recurrence within 24 months) History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug * Surgery or local prostatic intervention within 30 days of the first dose * Radiotherapy or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 Day 1 * Any acute toxicities due to prior therapy that have not resolved to a NCI CTCAE (version 3.0) grade of \<=1 * More than one prior cytotoxic chemotherapy or biologic therapy for treatment of CRPC * Prior chemotherapy with mitoxantrone or other anthracyclines (ie, doxorubicin, daunomycin, epirubicin and idarubicin) * Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1 * Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1 Day 1 * Prior bicalutamide (Casodex), nilutamide (Nilandron, Anandron) within 6 weeks of Cycle 1 Day 1 * Previous abiraterone acetate or other investigational CYP17 inhibitor (eg, TAK-700) * Previous investigational antiandrogens (eg, MDV3100, BMS-641988) * Patients receiving anti-coagulant therapy * Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study