Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of Part 1 of this study is to determine the maximally tolerated dose of OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).

The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of OPC-108459 for the treatment of paroxysmal and persistent atrial fibrillation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Criteria

Inclusion Criteria:

• Subjects with paroxysmal atrial fibrillation (AF) (recent or new onset) or subjects with persistent AF at the time of randomization

• Subjects who are hemodynamically stable

• Subjects with a low risk of thromboembolic potential

• Subjects who are willing to comply with the reproductive precautions

Exclusion Criteria:

Subjects with:

• History of long QT syndrome, Torsade de Pointes or an uncorrected QT interval of > 450 ms

• History of myocardial infarction within 6 months of screening

• Acute coronary syndrome, angina or active myocardial ischemia diagnosed by ECG, or other imaging within 6 months of screening

• History of ventricular tachycardia, fibrillation, or resuscitated cardiac arrest

• History of clinically significant congenital heart disease

• Presence of severe aortic or mitral stenosis, aortic or mitral regurgitation, atrial septal defect, or other conditions leading to AF

• Diagnosis of heart failure NYHA Class II-IV or with an ejection fraction <40% (Part 1 only)

• Diagnosis of heart failure NYHA Class IV or NYHA I, II, or III with an ejection fraction <35% (Part 2 only)

• Concomitant treatment with class I or III anti-arrhythmics agents unless the medication was discontinued more than 5 half-lives before dosing

• History of seizures

• Diagnosis of atrial flutter

• Diagnosis of stroke, TIA (transient ischemic attack), or any transient neurological deficit within 1 year of screening or known carotid artery stenosis of >50%

• Cardiac surgery within 3 months of screening

• Bradycardia (< 50 bpm) or sick sinus syndrome, unless controlled by a pacemaker

• Current reversible cause of AF

• Wolff-Parkinson-White syndrome

• Any congenital abnormality, severe valve disease

• Subjects who have taken another investigational product within 30 days of dosing