Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation (CADENCE 215)
Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Paroxysmal Atrial fibrillation, Persistent Atrial fibrillation, A-fib
Eligibility 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
Sites / Locations
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
- Otsuka Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Persistent or Paroxysmal AF Part 1: OPC-108459
Persistent or Paroxysmal AF Part 1: Placebo
Persistent or Paroxysmal AF Part 2: OPC-108459
Placebo Part 2
To safely meet each of the following Cmax targets: 1.0-10.0 µg/mL. There will be 9 cohorts in all: 1.0, 1.6, 2.4, 3.6, 5.4, 7.0, 8.0, 9.0, and 10.0.
Single dose to safely meet target concentration from Part 1, if subject fails to convert to sinus rhythm within 10 minutes, second dose will be administered to achieve 25% increase when compared to first infusion