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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01483183
Other study ID # 269-11-215
Secondary ID
Status Terminated
Phase Phase 1
First received November 29, 2011
Last updated December 11, 2015
Start date November 2011
Est. completion date October 2015

Study information

Verified date December 2015
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyItaly: National Institute of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


Description:

This trial will test the pharmacokinetic and pharmacodynamic characteristics of ascending doses of OPC-108459 in separate populations of paroxysmal and persistent AF subjects.

The trial will consist of two parts. Each part will evaluate two populations of subjects presenting for cardioversion in a hospital setting.

Cohorts of paroxysmal and persistent subjects may have their dose increased independently.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
OPC-108459
Part 1: single dose OPC-108459, 10-minute constant rate IV infusion to achieve specified Cmax target Part 2: single dose OPC-108459, 10-minute constant rate IV infusion to achieve Cmax target concentration from Part 1; if failure to convert to sinus rhythm, second dose OPC-108459 administered, 10-minute constant rate IV infusion to achieve target concentration from Part 1
Placebo
Placebo dose, 10-minute constant rate IV infusion

Locations

Country Name City State
Germany Otsuka Investigational Site Berlin
Germany Otsuka Investigational Site Hamburg
Germany Otsuka Investigational Site Leipzig
Germany Otsuka Investigational Site Pirna
Italy Otsuka Investigational Site Ancona
Italy Otsuka Investigational Site Bologna
Italy Otsuka Investigational Site Cremona
Italy Otsuka Investigational Site San Fermo Como
Netherlands Otsuka Investigational Site Amsterdam
Netherlands Otsuka Investigational Site Groningen
Spain Otsuka Investigational Site Barcelona
Spain Otsuka Investigational Site Fuenlabrada Madrid
Spain Otsuka Investigational Site Granada
Spain Otsuka Investigational Site Madrid
Spain Otsuka Investigational Site Madrid
United Kingdom Otsuka Investigational Site Chertsey Surrey
United States Otsuka Investigational Site Germantown Tennessee
United States Otsuka Investigational Site Hollywood Florida
United States Otsuka Investigational Site Houston Texas
United States Otsuka Investigational Site Jacksonville Florida
United States Otsuka Investigational Site Johnson City New York
United States Otsuka Investigational Site Lexington Kentucky
United States Otsuka Investigational Site New Orleans Louisiana
United States Otsuka Investigational Site Sarasota Florida
United States Otsuka Investigational Site Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Peak plasma concentration (Cmax) 24 hours No
Primary Part 1: Area under the concentration-time curve (AUCt) 24 hours No
Primary Part 1:QT interval corrected for heart rate using the Fridericia formula (QTcF) QT= Uncorrected interval from onset of QRS complex to end of T wave. Measured using Holter monitor and local ECG readings. 24 hours Yes
Primary Part 1: Ventricular rate 24 hours Yes
Primary Part 1: Diastolic and systolic blood pressure 24 hours Yes
Primary Part 2: Percent of subjects with normal sinus rhythm (NSR) 30 minutes No
Primary Part 2/1 infusion: Cmax 24 hours No
Primary Part 2/2 infusions: Cmax 24 hours No
Primary Part 2/1 infusion: AUCt 24 hours No
Primary Part 2/2 infusions: AUCt 24 hours No
Primary Part 2: QTcF 24 hours Yes
Primary Part 2: Ventricular rate 24 hours Yes
Primary Part 2: Diastolic and systolic blood pressure 24 hours Yes
Secondary Part 1: Percentage of subjects with NSR 24 hours No
Secondary Part 2: Time to NSR 24 hours No
Secondary Part 2: Duration of NSR 24 hours No
Secondary Part 2: Duration of NSR 168 hours No
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