To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial fibrillation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Unnamed facility
Kyushu Region, Japan
Subjects Achieving Normal Sinus Rhythm (NSR) in Patients With Paroxysmal AF
24 subjects with paroxysmal AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute.
Time frame: 90 minutes
Subjects Achieving NSR in Patients With Persistent AF
24 subjects with persistent AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute. No subjects achieved NSR within 90 minutes after the start of IMP administration in the persistent AF cohort.
Time frame: 90 minutes
Cmax of Plasma OPC-108459 in Patients With Paroxysmal AF
Of 20 subjects for whom plasma OPC-108459 concentrations were measured, 19 subjects were included in the PK analysis, and one subject was excluded.
Time frame: 0, 30, 50 minute and 2, 4, 8, 24 hour
Cmax of Plasma OPC-108459 in Patients With Persistent AF
Of 20 subjects for whom plasma OPC-108459 concentrations were measured, all subjects were included in the PK analysis.
Time frame: 0, 30, 50 minute and 2, 4, 8, 24 hour
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