A Multi-center, Parallel-group, Double-blind, Placebo-controlled, Randomized, Ascending Dose Trial to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Infusions of OPC-108459 Administered to Subjects with Paroxysmal and Persistent Atrial Fibrillation.

A Multi-center, Parallel-group, Double-blind, Placebo-controlled, Randomized, Ascending Dose Trial to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Infusions of OPC-108459 Administered to Subjects with Paroxysmal and Persistent Atrial Fibrillation. - OPC-108459 in Subjects with Paroxysmal & Persistent Atrial Fibrillation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41577

Enrollment

Registered

2013-12-10

Start date

2014-01-05

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac arrhythmias irregular hartbeat

Interventions

Investigational Medicinal Product, Dose, Formulation, Mode of Administration: OPC-108459 powder, 50 mg, will be packaged in 50-mL sterile vials. OPC-108459 powder in 50-mL vials will be reconstituted

the estimates are based on a slope of 4,000 ng/mL per mg/kg dose of OPC-108459 that was observed in the healthy subject trial (269-09-201). Should the slope change, doses will be adjusted to produce

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male and female subjects, ages of legal consent up to 85 years old, inclusive. 2. Patients with paroxysmal AF (recent or new onset) duration defined as 3 hours to 7 days and

Exclusion criteria

Exclusion criteria: 1. History of long QT syndrome, Torsade de Pointes or an uncorrected QT interval of > 450 msec. 2. QRS interval > 120 msec at Screening. 3. History of myocardial infarction within 6 months of Screening. 4. Symptoms of acute coronary syndrome, angina, or active myocardial ischemia diagnosed by ECG, or imaging stress testing within 6 months of Screening. 5. History of ventricular tachycardia, fibrillation, or resuscitated cardiac arrest. 6. History of clinically significant congenital heart disease. 7. Presence of severe aortic or mitral stenosis (valve area 50%. 14. Cardiac surgery within 3 months of Screening. 15. Bradycardia (= 1.8 g/dL, hemoglobin

Design outcomes

Primary

Measure	Time frame
Primary Endpoints (Part 1): PK: •For OPC-108459: Cmax and area under the concentration-time curve from time 0 to time of the last measurable concentration (AUCt). Safety: •Maximum change from baseline in Holter collected QTcF in the 24-hour postdose interval; •Maximum change from baseline in Holter collected ventricular rate in the 24-hour postdose interval; •Maximum change from baseline in diastolic and systolic blood pressure collected during vital sign measurements in the 24-hour postdose interval. Primary Endpoints (Part 2): Efficacy: •Percent of subjects with NSR, defined as NSR for at least 1 minute within 30 minutes of the end of OPC-108459 infusion. PK: (Subjects to be analyzed separately for 1 or 2 infusions) •For OPC-108459: Cmax and AUCt. Safety: •Maximum change from baseline in Holter collected QTcF in the 24-hour postdose interval; •Maximum change from baseline in Holter recorded ventricular rate in the 24-hour postdose interval; •*Maximum change from baseline in diastolic and systolic blood pressure collected during vital sign measurements in the 24-hour postdose interval.	—

Measure

Time frame

Primary Endpoints (Part 1): PK: •*For OPC-108459: Cmax and area under the concentration-time curve from time 0 to time of the last measurable concentration (AUCt). Safety: •*Maximum change from baseline in Holter collected QTcF in the 24-hour postdose interval; •*Maximum change from baseline in Holter collected ventricular rate in the 24-hour postdose interval; •*Maximum change from baseline in diastolic and systolic blood pressure collected during vital sign measurements in the 24-hour postdose interval. Primary Endpoints (Part 2): Efficacy: •*Percent of subjects with NSR, defined as NSR for at least 1 minute within 30 minutes of the end of OPC-108459 infusion. PK: (Subjects to be analyzed separately for 1 or 2 infusions) •*For OPC-108459: Cmax and AUCt. Safety: •*Maximum change from baseline in Holter collected QTcF in the 24-hour postdose interval; •*Maximum change from baseline in Holter recorded ventricular rate in the 24-hour postdose interval; •*Maximum change from baseline in diastolic and systolic blood pressure collected during vital sign measurements in the 24-hour postdose interval.

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Secondary

Measure	Time frame
Secondary Endpoints (Part 1): Efficacy: •Percent of subjects with NSR, defined as NSR for at least 1 minute within 30 minutes of the end of OPC-108459 infusion. Secondary Endpoints (Part 2): Efficacy: •Time to achievement of NSR (for those that convert); •*Duration of NSR up to 24 hours and presence of NSR at 168 hours (8 days).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)