Study of Oral PKN605 to Reduce Atrial Fibrillation Burden and Evaluate Safety and Pharmacokinetics in Adults With Atrial Fibrillation

What this Trial Is About

Researchers are evaluating the effect of PKN605, an oral medication, on atrial fibrillation, a condition affecting heart rhythm. This Phase 2 study is designed as a randomized, double-blind, placebo-controlled trial to assess how well PKN605 reduces the time participants spend in atrial fibrillation, as well as its safety, tolerability, and how the body processes the drug. The study is sponsored by Novartis Pharmaceuticals and aims to provide detailed information about the treatments impact on this heart condition. Participants will first undergo a screening period of up to 90 days to confirm eligibility. Those who qualify will be randomly assigned to receive one of two doses of PKN605 or a matching placebo. The treatment phase lasts 24 weeks, during which participants take the oral study drug and attend clinic visits about once a month. Their heart rhythm will be monitored using ECG devices throughout the study. After completing treatment, participants will have a final safety follow-up visit approximately one month later. During the study, participants will have regular ECG monitoring to measure atrial fibrillation burden and check for recurrence. Additional assessments include pharmacokinetic sampling to measure drug concentration at specific times after dosing. Researchers will evaluate the primary outcome of atrial fibrillation burden over 24 weeks and secondary outcomes related to recurrence and drug levels. Safety and tolerability are closely monitored, and participants usual heart care continues alongside study participation.

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