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

Acesion Pharma

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Placebo; Drug: AP30663

Study type: Interventional

Funder types: Industry

Identifiers

NCT04571385

2018-004445-17 (EudraCT Number)

AP30663-2001

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 4 patient groups, including a placebo group

Part 1: AP30663

Experimental group

Description:

Participants will receive single dose of AP30663.

Treatment:

Drug: AP30663

Part 1: Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to AP30663.

Treatment:

Drug: Placebo

Part 2: AP30663

Experimental group

Description:

Participants will receive a single dose of one of the multiple dose levels of AP30663.

Treatment:

Drug: AP30663

Part 2: Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to AP30663.

Treatment:

Drug: Placebo