A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2022-08-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HSY244 in participants with atrial fibrillation (AF), with and without heart failure (HF).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Hemodynamically stable men and women between 18 and 80 years of age with a clinical indication for direct current cardioversion of AF

• Current episode of AF has been ongoing for >= 6 hours and =< 30 days

• Successful initiation and achievement of therapeutic levels of national guideline and institution-specific anticoagulation therapy as appropriate for the duration of the AF episode and risk for the participant

• Completion of national guideline and institution-specific imaging evaluation for left atrial thrombi as appropriate for the duration of AF episode and risk for the participant

• Participants must weigh at least 60 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 45 kg/m2. BMI = Body weight (kg) / [Height (m)2]

• Written informed consent must be obtained before any assessment is performed and only participants able to provide written informed consent themselves will be included in this study

Key Exclusion Criteria:

• Use of any class I or III anti-arrhythmic medication, or other prohibited medications, within 5 half-lives before randomization, including use of amiodarone within 3 months before randomization

• History or current diagnosis of electrocardiogram (ECG) abnormalities or cardiac rhythm disorders indicating significant risk of safety for participant as determined by the Investigator's interpretation of the ECG findings

• Clinically significant sinus node dysfunction and/or presence of a permanent pacemaker

• Attempted or unsuccessful cardioversion within 2 weeks prior to randomization

• History of 2 or more ablation procedures for AF

• Presence of known severe mitral regurgitation and/or known severely dilated left atrium

• Pre-existing or tachycardia-induced moderate to severe cardiac dysfunction (New York Heart Association class III or IV)

• History within the preceding 3 months prior to randomization of either a: myocardial infarction, unstable angina, cardiac surgery, or a percutaneous coronary intervention

• History of confirmed stroke or transient ischemic attack (TIA)

• History or current diagnosis of any seizure disorder or major neurological disorder or major psychiatric disorder

• Sexually active males, including those post-vasectomy, must use a condom during sexual intercourse for at least 96 hours after dosing to prevent delivery of the drug via seminal fluid and should not father a child during this period

• Women must be either of non-childbearing potential or child-bearing potential using highly effective non-hormonal contraception

Other protocol-defined inclusion/exclusion may apply