Objective
The purpose of this study is to evaluate the efficacy in reducing atrial fibrillation burden (AFB) as well as the safety, tolerability and pharmacokinetics of oral PKN605 in adult participants with atrial fibrillation (AF). The results of the study will be used to inform future development plans for PKN605.
Background
Atrial fibrillation is a heart rhythm issue that becomes more common with age. It is often controlled with either rate control or rhythm control strategies. Rhythm control drugs aim to restore sinus rhythm in patients with atrial fibrillation. However, some of these drugs have undesirable cardiac and systemic side effects. PKN605 is a new drug that restores sinus rhythm through a new mechanism.
Study Outcomes
Primary
- To evaluate the effect of PKN605 on atrial fibrillation burden
Secondary
- To evaluate the effect of PKN605 on AF recurrence
- To evaluate the safety and tolerability of PKN605 in participants with atrial fibrillation
- To evaluate the pharmacokinetics of PKN605 in participants with atrial fibrillation
Eligibility Criteria
The criteria below are a summary. Your study doctor will confirm whether this study is right for you.
Inclusion Criteria
- Signed informed consent must be obtained prior to participation in the study.
- Male and female participants ≥ 18 years of age
- History of at least 2 episodes of AF (atrial fibrillation or atrial flutter), at least one episode
- must be atrial fibrillation
- At least one of the AF episodes specified in Inclusion #3 must be within the last 12
- months (or during Screening) and documented by 12-lead, ECG, Holter, or any other
- ECG recording method, as confirmed by the Investigator
- One or more of the following, at Screening: AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months, CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females, Stable heart failure or with New York Heart Association class I or II symptoms, NT-proBNP level of 300 pg/mL or higher on a local lab test within the last 12 months
- On guideline-directed stroke prevention treatment, as confirmed by the investigator, at
- Screening
- Ability to wear an ECG patch monitor during the Screening phase for a minimum of 4
- days (96 hours)
- Participants must have a body mass index (BMI) ≥18 kg/m2. BMI is calculated as body
- weight (kg) divided by height in (m) squared
- Able to communicate well with the Investigator, to understand and comply with the
- requirements of the study.
Exclusion Criteria
- Permanent AF
- Ongoing reversible cause of AF (e.g., hyperthyroidism, myocarditis, alcohol use, sepsisor
- infection-related AF, surgery-related AF, pulmonary embolism)
- Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III antiarrhythmic
- therapy must be discontinued at least 7 days before Screening phase ECG patch monitor;
- amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch
- monitor)
- History of an AF ablation procedure without a recurrence of AF at least 2 or more months
- after the ablation.
- Implanted pacemaker, defibrillator, or cardiac monitor
- Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy
- Current decompensated heart failure or hospitalization for heart failure within 3 months
- prior to Screening.
- Left ventricular ejection fraction (LVEF) of 40% or less documented within the last 12
- months, or during the Screening period. If multiple LVEF measurements are recorded
- within the last 12 months, the most recent LVEF measurement must be used to determine
- eligibility.
- Severe valvular disease or planned valvular intervention during study
- Stroke within the last 6 months, or other neurologic or psychiatric conditions likely to
- affect study compliance
- Cardiac surgery within the last 6 months
- Unstable angina, myocardial infarction, coronary angioplasty within the last 6 months
- Known allergic reactions to adhesives or hydrogels
About taking part
If you would like to learn more about taking part in this study, please contact our research team using the details on this page. We can walk you through what participation involves and answer any questions.