SuspendedPhase 1ACTRN12611000373976

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.

Sponsor

Bristol-Myers Squibb

Enrollment

88 participants

Start Date

May 9, 2011

Study Type

Interventional

Conditions

Atrial Fibrillation

Summary

The purpose of this study is to assess the safety and tolerability of BMS-919373 in healthy subjects.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This is a safety study testing a new drug called BMS-919373 in healthy volunteers. Researchers give increasing doses to both younger adults (18-45) and older adults (65+) to find out how the body handles the drug and whether it causes any side effects, particularly related to the heart.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 followin

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).