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

What this Trial Is About

Researchers are evaluating the effectiveness, safety, tolerability, and how the body processes PKN605 in adults with atrial fibrillation. This Phase 2 study compares PKN605 to a placebo to see if it can reduce the amount of time participants experience atrial fibrillation. The trial is randomized, placebo-controlled, and both participants and investigators are blinded to the assigned treatment. The study begins with a screening period lasting up to 90 days to confirm eligibility. After that, participants are randomly assigned to receive either PKN605, given orally at two different dose levels, or a matching oral placebo. The treatment phase lasts 24 weeks, with clinic visits roughly once a month. Atrial fibrillation burden is monitored throughout using various ECG devices. About one month after treatment ends, participants have a final safety follow-up visit. During the study, participants will undergo regular ECG monitoring to track atrial fibrillation episodes. Researchers will measure atrial fibrillation burden using ECG patch monitors over 24 weeks as the primary outcome. Secondary outcomes include the time to first atrial fibrillation recurrence, presence of recurrence, and drug concentration levels at specified times. The study includes safety and tolerability assessments, with total participation lasting approximately 7 months including screening and follow-up.

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