RecruitingPhase 2NCT07217067

A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation

A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Evaluate the Efficacy in Reducing Atrial Fibrillation Burden (AFB) as Well as the Safety, Tolerability, and Pharmacokinetics of Oral PKN605 in Participants With Atrial Fibrillation

Sponsor

Novartis Pharmaceuticals

Enrollment

165 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called PKN605 for people who have atrial fibrillation (AFib) — an irregular heartbeat that increases the risk of stroke and other heart problems. Researchers want to see if PKN605 is safe and effective at managing AFib. **You may be eligible if...** - You are 18 or older and have had at least 2 episodes of AFib - At least one AFib episode was in the past 12 months, confirmed by a heart monitor or ECG - You are currently in a normal heart rhythm (or can be safely reset to one before the study starts) - You are on stroke prevention medication as recommended by your doctor - You have a healthy body weight (BMI of 18 or above) **You may NOT be eligible if...** - You have severe, unstable heart failure (NYHA class III or IV) - You have had a stroke or certain other serious heart conditions recently - You are taking certain medications that cannot be safely combined with the study drug - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPKN605

PKN605 is an oral formulation

OTHERPlacebo

Matching placebo

Locations(38)

Cardiology Associates of North MS

Tupelo, Mississippi, United States

Weill Cornell Medical Center

New York, New York, United States

Duke Univ Medical Center

Durham, North Carolina, United States

Intermountain Medical Center

Murray, Utah, United States

Swedish Heart and Vascular Clinic

Seattle, Washington, United States

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

Hamilton, Ontario, Canada

Novartis Investigative Site

London, Ontario, Canada

Novartis Investigative Site

Newmarket, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Sherbrooke, Quebec, Canada

Novartis Investigative Site

Beijing, Beijing Municipality, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Xi'an, China

Novartis Investigative Site

Bad Homburg, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Arnhem, Gelderland, Netherlands

Novartis Investigative Site

Maastricht, Limburg, Netherlands

Novartis Investigative Site

Delft, South Holland, Netherlands

Novartis Investigative Site

Goes, Zeeland, Netherlands

Novartis Investigative Site

Groningen, Netherlands

Novartis Investigative Site

Veldhoven, Netherlands

Novartis Investigative Site

Singapore, Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Brighton, East Sussex, United Kingdom

Novartis Investigative Site

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Novartis Investigative Site

Liverpool, United Kingdom

Novartis Investigative Site

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07217067

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