NCT02153437

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 atrial-fibrillation

Timeline
Completed

Started Oct 2014

Typical duration for phase_1 atrial-fibrillation

Geographic Reach
2 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

October 30, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2016

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

May 30, 2014

Last Update Submit

December 17, 2023

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker

    At 0.5, 1, 2, and 4 hours following study drug administration

Secondary Outcomes (5)

  • The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests

    At 1, 2, and 4 hours following study drug administration

  • Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline

    At 2 hour following study drug administration

  • Safety assessments based on Atrioventricular interval (AVI) and change from baseline

    At 1, 2, and 4 hours following study drug administration

  • Safety assessments based on Wenckebach cycle length (WCL) and change from baseline

    At 1, 2, and 4 hours following study drug administration

  • Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline

    At 1, 2, and 4 hours following study drug administration

Study Arms (3)

Arm A: BMS-919373

EXPERIMENTAL

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

Drug: BMS-919373

Arm B: Sotalol

ACTIVE COMPARATOR

Sotalol oral Tablet single dose for one day

Drug: Sotalol

Arm C: Placebo for BMS-919373

PLACEBO COMPARATOR

Oral solution/tablet one single dose for one day

Drug: Placebo for BMS-919373

Interventions

BMS-919373DRUG
Also known as: iKUR
Arm A: BMS-919373
SotalolDRUG
Also known as: Co Sotalol
Arm B: Sotalol
Placebo for BMS-919373DRUG
Arm C: Placebo for BMS-919373

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years to 85 years.
  • Eligible patients will have a dual-chamber permanent pacemaker.
  • Women who are not of childbearing potential.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Local Institution

Austin, Texas, 78705, United States

Location

The University Of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University Of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Local Institution - 0001

Toronto, Ontario, M5B 1W8, Canada

Location

Local Institution - 0002

Montreal, Quebec, H1T 1C8, Canada

Location

Local Institution

Montreal, Quebec, H2W 1T8, Canada

Location

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Sotalol

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 3, 2014

Study Start

October 30, 2014

Primary Completion

October 20, 2016

Study Completion

October 20, 2016

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations

CA(5)US(1)