Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers

Study Overview
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Brief Summary
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To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.

Official Title
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A Study of the Effects of BMS-919373 on Atrial Effective Refractory Period in Subjects With a Dual-Chamber Pacemaker

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: BMS-919373
* Drug: Sotalol
* Drug: Placebo for BMS-919373


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria Age 18 years to 85 years. Eligible patients will have a dual-chamber permanent pacemaker. Women who are not of childbearing potential. Exclusion Criteria - Patients with a history of Atrial Fibrillation (AF) that is either:. i) Permanent (i.e. patients are only in AF and never in sinus rhythm) or. ii) Persistent (i.e. patients who's episodes of AF are longer than 7 days and require medical intervention, such as electrical or medical cardioversion, to return to sinus rhythm), are excluded. History of Transient Ischemic Attack (TIA) or stroke in the last 12 months. History of clinically significant ventricular arrhythmia (not including isolated monomorphic Premature Ventricular Contractions (PVCs)). Such arrhythmias are marked by loss of consciousness, emergent cardioversion or defibrillation or unstable vital signs requiring medical intervention. Complete heart block. Planned surgery, endovascular intervention or cardioversion within the study period. History of atrial fibrillation. Other protocol-defined Inclusion/Exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: BMS-919373<br>BMS-919373 oral Solution/tablet single dose for one day | Drug: BMS-919373<br> <br> * Other names: iKUR;|
| Active Comparator: Arm B: Sotalol<br>Sotalol oral Tablet single dose for one day | Drug: Sotalol<br> <br> * Other names: Co Sotalol;|
| Placebo Comparator: Arm C: Placebo for BMS-919373<br>Oral solution/tablet one single dose for one day | Drug: Placebo for BMS-919373<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker |  | At 0.5, 1, 2, and 4 hours following study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests |  | At 1, 2, and 4 hours following study drug administration | 
| Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline |  | At 2 hour following study drug administration | 
| Safety assessments based on Atrioventricular interval (AVI) and change from baseline |  | At 1, 2, and 4 hours following study drug administration | 
| Safety assessments based on Wenckebach cycle length (WCL) and change from baseline |  | At 1, 2, and 4 hours following study drug administration | 
| Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline |  | At 1, 2, and 4 hours following study drug administration |