Placebo-Controlled, Single and Multiple Ascending Dose Study of BMS-919373 in Healthy Subjects.

PART A: The treatment groups have been completed and subjects received a single dose of either 10 mg, 30 mg, and 100 mg of BMS-919373 or placebo. Based on exposures from these subjects, the following doses are selected for the remainder of Part A of this study: Treatment Group 4: Subjects will receive a single 30 mg oral dose of BMS-919373 or placebo (suspension), in Period 1, followed by a single 30 mg dose of BMS-919373 or placebo following the administration of 40 mg famotidine in Period 2, followed by a single 30 mg dose of BMS-919373 or placebo following the administration of a high fat breakfast in Period 3. There will be at least 5 days between each dose. Treatment Groups 5: Subjects will receive a single 1 mg oral dose of BMS-919373 or placebo (solution). Treatment Group 6: Subjects will receive a single 10 mg oral dose of BMS-919373 or placebo (solution) in Period 1 followed by a single 10 mg oral dose of BMS-919373 or placebo (suspension) in Period 2. Treatment Group 7: Subjects will receive a single 100 mg oral dose (repeat of Panel 3, with extended sampling) of BMS-919373 or placebo (suspension formulation). PART B: Eight healthy subjects will be assigned to each of up to 4 sequential dose treatment groups in the MAD. Each subject will be administered a daily oral dose of BMS-919373 or placebo for 14 days. The following doses will be studied: Treatment Group 1: 3 mg loading dose (LD) on Day 1, followed by 1mg QD of BMS-919373 or placebo on Days 2-14 (solution). Treatment Group 2: 30 mg LD on Day 1, followed by 10 mg QD of BMS-919373 or placebo on Days 2-14 (suspension). Treatment Group 3: 90 mg LD on Day 1, followed by 30 mg QD of BMS-919373 or placebo on Days 2-14 (suspension). In this panel, 2 mg midazolam will be administered 2 days prior to the initial dose of BMS-919373and again on Day 15, within 5 minutes after receiving BMS-919373 or placebo. Treatment Group 4: elderly subjects will be administered a 90mg LD + 30 mg MD of BMS-919373 or placebo (suspension).