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

Condition(s): Heart Diseases
NCTId: NCT00162448

Official Title

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

Summary

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

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 18 Years 80 Years False

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

Interventions & Outcomes

Study Interventions & Types

Drug Intervention(s)

BMS-394136 - Oral Solution, Oral, 100 mg, Single dose, 1 day.
Placebo - Oral Solution, Oral, 0 mg, Single dose, 1 day.

Study Outcomes

Primary Outcome(s)

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

Secondary Outcome(s)

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

Measure: Effect of BMS-394136 on atrial vs ventricular refractoriness
Timeframe:

Measure: Effect of BMS-394136 on the QTc interval
Timeframe:

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

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status

Clinical Research Study Facility Locations

Local Institution
Columbus, Ohio United States

Local Institution
Ann Arbor, Michigan United States

Local Institution
Salisbury, Maryland United States

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Heart Diseases

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