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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: AP30663; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Vestbjerg; Phone Number: +4520772575; Email: bve@acesionpharma.com

Study Locations

• Denmark
  • Aalborg, Denmark
    • Acesion Pharma Investigational Site 110
  • Copenhagen, Denmark
    • Acesion Pharma Investigational Site 106
  • Hellerup, Denmark
    • Acesion Pharma Investigational Site 108
  • Hillerød, Denmark
    • Acesion Pharma Investigational Site 113
  • Roskilde, Denmark
    • Acesion Pharma Investigational Site 105
• Hungary
  • Budapest, Hungary
    • Acesion Pharma Investigational Site 202
  • Budapest, Hungary
    • Acesion Pharma Investigational Site 203
  • Budapest, Hungary
    • Acesion Pharma Investigational Site 207
  • Budapest, Hungary
    • Acesion Pharma Investigational Site 212
  • Budapest, Hungary
    • Acesion Pharma Investigational Site 213
  • Budapest, Hungary
    • Acesion Pharma Investigational Site 214
  • Pecs, Hungary
    • Acesion Pharma Investigational Site 211
  • Szekszárd, Hungary
    • Acesion Pharma Investigational Site 201
  • Szentes, Hungary
    • Acesion Pharma Investigational Site 210
  • Zalaegerszeg, Hungary
    • Acesion Pharma Investigational Site 204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Acesion Pharma

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): January 23, 2023

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AP30663-2001; 2018-004445-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No