Placebo-Controlled, Single and Multiple Ascending Dose Study of BMS-919373 in Healthy Subjects.
Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of BMS-919373 in Healthy Subjects.
Bristol-Myers Squibb
88 participants
May 9, 2011
Interventional
Conditions
Summary
The purpose of this study is to assess the safety and tolerability of BMS-919373 in healthy subjects.
Eligibility
Inclusion Criteria3
- Healthy subjects: women and men, ages 18 to 45
- Healthy elderly subjects: post-menopausal women and men greater than or equal to 65 years of age.
- Body mass index (BMI) of 18 to 32kg/m2, inclusive.
Exclusion Criteria6
- Current or history of cardiovascular diseases.
- Healthy young subjects: resting heart rate of less than 45 beats/min and greater than 90 beats/min at screening.
- Healthy elderly subjects: Resting heart rate of less than 50 beats/min and greater than 90 beats/min at screening.
- QTcF greater than 450 msec at screening.
- Any clinical significant finding during pre-dose telemetry or ECG monitoring.
- Current or history of neurological diseases or mental disorders current or history of kidney diseases.
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Interventions
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).
Locations(1)
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ACTRN12611000373976