A Phase 1 QT Study in Healthy Male Subjects

A total of 72 male subjects will be randomized and enrolled, with 18 subjects assigned to each treatment sequence. For each treatment sequence, each subject will participate in a screening phase, four baseline phases, four treatment periods and a follow up visit. Within 28 days prior to Period 1 dosing, subjects will sign an informed consent document (ICD) and undergo screening procedures to confirm eligibility. Qualifying subjects will return to the clinical site on Day -2 of Period 1 to begin baseline assessments, and will be domiciled at the clinical site from Day -2 to Day 2 of Period 1. For all remaining study periods, subjects will return to the clinical site on Day -1 to begin baseline assessments, and will be domiciled at the clinical site from Day -1 to Day 2. Subjects will be assigned randomly to one of four treatment sequences and will receive a single dose of the assigned treatment on Day 1 of each study period. There will be a minimum of 7 days and no more than 14 days between each dose. Subjects will begin an overnight fast of at least 8 hours prior to the start of continuous Holter monitoring on Day 1 (and Day 1 in Period 1). On the morning of Day 1 (and Day -1 in Period 1), continuous Holter monitoring for approximately 24 hours will be performed. Triplicate ECGs will be extracted for analysis at specific predose and postdose timepoints (or equivalent times on Day -1 of Period 1). Blood samples will be collected at pre specified timepoints for pharmacokinetic (PK) and clinical laboratory assessments. Safety will be monitored throughout the study. During each study period, subjects will be discharged from the clinical site on Day 2 upon satisfactory safety review and completion of the required study procedures. A safety follow up will be conducted by telephone 5 to 7 days following discharge in Period 4. In the event that a subject discontinues from the study, an early termination visit will be performed.