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

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

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

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: BMS-919373; Drug: Sotalol; Drug: Placebo for BMS-919373

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • The University Of Calgary
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
    • Toronto, Ontario, Canada, M5B 1W8
      • Local Institution - 0001
  • Quebec
    • Montreal, Quebec, Canada, H2W 1T8
      • Local Institution
    • Montreal, Quebec, Canada, H1T 1C8
      • Local Institution - 0002
• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2014
• Primary Completion (Actual): October 20, 2016
• Study Completion (Actual): October 20, 2016

Study Registration Dates

• First Submitted: May 30, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimated): June 3, 2014

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Sotalol
• Other Study ID Numbers: CV205-006