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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02153437
First received: May 30, 2014
Last updated: August 28, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
Drug: BMS-919373
Drug: Sotalol
Drug: Placebo for BMS-919373
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline [ Time Frame: At 2 hour following study drug administration ] [ Designated as safety issue: Yes ]
  • Safety assessments based on Atrioventricular interval (AVI) and change from baseline [ Time Frame: At 1, 2, and 4 hours following study drug administration ] [ Designated as safety issue: Yes ]
  • Safety assessments based on Wenckebach cycle length (WCL) and change from baseline [ Time Frame: At 1, 2, and 4 hours following study drug administration ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: BMS-919373
BMS-919373 oral Solution single dose for one day
Drug: BMS-919373
Other Name: iKUR
Active Comparator: Arm B: Sotalol
Sotalol oral Tablet single dose for one day
Drug: Sotalol
Other Name: Co Sotalol
Placebo Comparator: Arm C: Placebo for BMS-919373
Oral solution one single dose for one day
Drug: Placebo for BMS-919373

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Eligible patients will have a dual-chamber permanent pacemaker without a history of atrial fibrillation
  • Women who are not of childbearing potential

Exclusion Criteria:

  • 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
  • Use of Statin therapy
  • History of atrial fibrillation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02153437

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
Canada, Ontario
Local Institution Not yet recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Site 0003         
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Site 0001         
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Site 0002         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02153437     History of Changes
Other Study ID Numbers: CV205-006
Study First Received: May 30, 2014
Last Updated: August 28, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Sotalol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014