A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators

Bristol-Myers Squibb36 enrolled

Overview

Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Heart Diseases

Interventions

BMS-394136DRUG

Oral Solution, Oral, 100 mg, Single dose, 1 day.

PlaceboDRUG

Oral Solution, Oral, 0 mg, Single dose, 1 day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with dual-chamber pacemakers or defibrillators Exclusion Criteria: * Recent acute ischemic events * Recent atrial or ventricular arrhythmias * Uncompensated heart failure * Amiodarone use within last year * Women of childbearing potential * QTc \<430 msec males * QTc \<450 msec females

Locations (3)

Local Institution

Salisbury, Maryland, United States

Local Institution

Ann Arbor, Michigan, United States

Local Institution

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)

Secondary Outcomes

Effect of BMS-394136 on atrial vs ventricular refractoriness

Effect of BMS-394136 on the QTc interval

Assess the safety and tolerability of a single dose of BMS-394136

Explore the relationship between plasma concentration of BMS-394136 and refractoriness

Data from ClinicalTrials.gov

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