Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers

Phase 1

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Drug: BMS-919373; Drug: Sotalol; Drug: Placebo for BMS-919373

• Registration Number: NCT02153437
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-30
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Study Start: 2014-10-30
• Primary Completion: 2016-10-20
• Study Completion: 2016-10-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-17
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: BMS-919373	BMS-919373	BMS-919373 oral Solution/tablet single dose for one day
Arm B: Sotalol	Sotalol	Sotalol oral Tablet single dose for one day
Arm C: Placebo for BMS-919373	Placebo for BMS-919373	Oral solution/tablet one single dose for one day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Local Institution - 0001; 🇨🇦 Toronto, Ontario, Canada

Local Institution; 🇨🇦 Montreal, Quebec, Canada

The University Of Calgary; 🇨🇦 Calgary, Alberta, Canada

University Of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Local Institution - 0002; 🇨🇦 Montreal, Quebec, Canada