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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162448

Enrollment

Registered

2005-09-13

Start date

2005-01-31

Completion date

Unknown

Last updated

2008-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

Patients requiring dual-chamber pacemakers or defibrillators

Brief 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

Interventions

DRUGBMS-394136

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026