Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-919373
Sotalol
Placebo for BMS-919373
Sponsored by
About this trial
This is an interventional basic science trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Local Institution
- The University Of Calgary
- University Of Ottawa Heart Institute
- St. Michael'S Hospital
- Montreal Heart Institute
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Arm A: BMS-919373
Arm B: Sotalol
Arm C: Placebo for BMS-919373
Arm Description
BMS-919373 oral Solution/tablet single dose for one day
Sotalol oral Tablet single dose for one day
Oral solution/tablet one single dose for one day
Outcomes
Primary Outcome Measures
The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker
Secondary Outcome Measures
The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests
Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline
Safety assessments based on Atrioventricular interval (AVI) and change from baseline
Safety assessments based on Wenckebach cycle length (WCL) and change from baseline
Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02153437
Brief Title
Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers
Official Title
A Study of the Effects of BMS-919373 on Atrial Effective Refractory Period in Subjects With a Dual-Chamber Pacemaker
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: BMS-919373
Arm Type
Experimental
Arm Description
BMS-919373 oral Solution/tablet single dose for one day
Arm Title
Arm B: Sotalol
Arm Type
Active Comparator
Arm Description
Sotalol oral Tablet single dose for one day
Arm Title
Arm C: Placebo for BMS-919373
Arm Type
Placebo Comparator
Arm Description
Oral solution/tablet one single dose for one day
Intervention Type
Drug
Intervention Name(s)
BMS-919373
Other Intervention Name(s)
iKUR
Intervention Type
Drug
Intervention Name(s)
Sotalol
Other Intervention Name(s)
Co Sotalol
Intervention Type
Drug
Intervention Name(s)
Placebo for BMS-919373
Primary Outcome Measure Information:
Title
The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker
Time Frame
At 0.5, 1, 2, and 4 hours following study drug administration
Secondary Outcome Measure Information:
Title
The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests
Time Frame
At 1, 2, and 4 hours following study drug administration
Title
Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline
Time Frame
At 2 hour following study drug administration
Title
Safety assessments based on Atrioventricular interval (AVI) and change from baseline
Time Frame
At 1, 2, and 4 hours following study drug administration
Title
Safety assessments based on Wenckebach cycle length (WCL) and change from baseline
Time Frame
At 1, 2, and 4 hours following study drug administration
Title
Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline
Time Frame
At 1, 2, and 4 hours following study drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
The University Of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University Of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
St. Michael'S Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers
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