A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)

Study Overview
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Brief Summary
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This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of one or more doses of AP30663 for cardioversion in adult participants with AF.

Official Title
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A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study of AP30663 Given Intravenously for Cardioversion in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: AP30663
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Clinical indication for cardioversion of AF Current episode of symptomatic AF lasting between 3-hour and 7 days (inclusive) at randomization Adequate anticoagulation according to international and/or national guidelines Key Exclusion Criteria: Significant clinical illness or surgical procedure within 4 weeks preceding the screening visit History of significant mental, renal or hepatic disorder, chronic obstructive pulmonary disease, sinus nodal disease, or other significant disease, as judged by the investigator. Any cardioversion attempt of AF or atrial flutter within 4 weeks preceding randomization Use of any antiarrhythmic drug class I and/or III within 6 months before randomisation Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: AP30663<br>Participants will receive single dose of AP30663. | Drug: AP30663<br>* Administer by intravenous infusion.<br>|
| Placebo Comparator: Part 1: Placebo<br>Participants will receive placebo matched to AP30663. | Drug: Placebo<br>* Placebo matched to AP30663.<br>|
| Experimental: Part 2: AP30663<br>Participants will receive a single dose of one of the multiple dose levels of AP30663. | Drug: AP30663<br>* Administer by intravenous infusion.<br>|
| Placebo Comparator: Part 2: Placebo<br>Participants will receive placebo matched to AP30663. | Drug: Placebo<br>* Placebo matched to AP30663.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants That Have Converted From AF and Subsequently Have no AF Recurrence Within 1 min of Conversion From AF |  | Within 90 Minutes From the Start of Infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Conversion From AF |  | From Start of Infusion up to Day 2 | 
| Proportion of Participants With Immediate Relapse of AF (IRAF) After Pharmacological or Direct-current (DC) Cardioversion |  | Within 5 Minutes After Cardioversion | 
| Proportion of Participants in Sinus Rhythm (SR) |  | At 3-hour After Start of Infusion | 
| Proportion of Participants in SR |  | At 24-hour After Start of Infusion | 
| Proportion of Participants in SR |  | At Day 30 After Start of Infusion | 
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Day 30 | 
| Changes in Fridericia's Correction of QT Interval (QTcF) Interval Data Over Time |  | Day 1 up to Day 2 | 
| Volume of Distribution (Vd) of AP30663 |  | Day 1 up to Day 2 | 
| Clearance (CL) of AP30663 |  | Day 1 up to Day 2 | 
| Peak Plasma Concentration (Cmax) of AP30663 |  | Day 1 up to Day 2 | 
| Time to Reach Peak Plasma Concentration (Tmax) of AP30663 |  | Day 1 up to Day 2 | 
| Terminal Half Life of (T1/2) of AP30663 |  | Day 1 up to Day 2 |