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

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Investigator)

Interventions

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

Arms, Groups and Cohorts

  • Experimental: A1
  • Placebo Comparator: A2

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.