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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Atrial Fibrillation

Treatments: Drug: BMS-919373; Drug: Placebo for BMS-919373; Drug: Sotalol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02153437

CV205-006

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7 participants in 3 patient groups, including a placebo group

Arm A: BMS-919373

Experimental group

Description:

BMS-919373 oral Solution/tablet single dose for one day

Treatment:

Drug: BMS-919373

Arm B: Sotalol

Active Comparator group

Description:

Sotalol oral Tablet single dose for one day

Treatment:

Drug: Sotalol

Arm C: Placebo for BMS-919373

Placebo Comparator group

Description:

Oral solution/tablet one single dose for one day

Treatment:

Drug: Placebo for BMS-919373