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PKN605

Effects of PKN605 on AFB

To investigate the efficacy, safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation

Lead PI & Sponsor

Dr. Habib Khan & Novartis Pharma AG

Local PI

Dr. Habib Khan

Research Staff

Andrea Carruthers

Objective

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 PKN605 in participants with atrial fibrillation

Target Number of Patients

165

Currently Enrolled

0

Primary Outcomes

  • To evaluate the effect of PKN605 on AFB

Secondary Outcomes

  • To evaluate the effect of PKN605 on AF recurrence
  • To evaluate the safety and tolerability of PKN605 in participants with AF
  • To evaluate the pharmacokinetics of PKN605 in participants with AF

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
  • At least 1 of the AF episodes specified in inclusion #3 (see Section 5.1) 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
  • On guideline-directed stroke prevention treatment, as confirmed by the Investigator
  • Participants must have a body mass index (BMI) ≥ 18 kg/m2 . BMI is calculated as body weight (kg) divided by height (m) squared

Exclusion Criteria

  • Permanent AF (> 3 years)
  • Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or 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 within the last 6 months 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
  • Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening
  • Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening

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.

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