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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT02153437
Collaborator
(none)
7
Enrollment
6
Locations
3
Arms
24
Duration (Months)
1.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Study of the Effects of BMS-919373 on Atrial Effective Refractory Period in Subjects With a Dual-Chamber Pacemaker
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline [At 2 hour following study drug administration]

    3. Safety assessments based on Atrioventricular interval (AVI) and change from baseline [At 1, 2, and 4 hours following study drug administration]

    4. Safety assessments based on Wenckebach cycle length (WCL) and change from baseline [At 1, 2, and 4 hours following study drug administration]

    5. Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline [At 1, 2, and 4 hours following study drug administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Austin Texas United States 78705
    2 The University Of Calgary Calgary Alberta Canada T2N 4N1
    3 University Of Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7
    4 St. Michael'S Hospital Toronto Ontario Canada M5B 1W8
    5 Montreal Heart Institute Montreal Quebec Canada H1T 1C8
    6 Local Institution Montreal Quebec Canada H2W 1T8

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02153437
    Other Study ID Numbers:
    • CV205-006
    First Posted:
    Jun 3, 2014
    Last Update Posted:
    Feb 15, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Sotalol

    Study Results

    No Results Posted as of Feb 15, 2017