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

NCT07217067 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CPKN605A12201
• Study Type: interventional
• Target: 165
• Locations: 7 countries
• Sites: 38

Brief 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

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Atrial fibrillation burden; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation burden from ECG patch monitors

  Defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time

  24 weeks

Secondary Outcomes (3)

• Time from the date of randomization to first atrial fibrillation recurrence

  24 weeks

• Presence of atrial fibrillation recurrence after randomization

  24 weeks

• Pharmacokinetic Parameter: concentration

  24 Weeks ( 0 hour(Pre-dose), 2 and 4 hour post dose)

Study Arms (3)

PKN605 lower dose

EXPERIMENTAL

PKN605 is an oral formulation

Drug: PKN605

PKN605 higher dose

EXPERIMENTAL

PKN605 is an oral formulation

Drug: PKN605

Placebo

PLACEBO COMPARATOR

Placebo is an oral formulation

Other: Placebo

Interventions

PKN605 DRUG

PKN605 is an oral formulation

PKN605 higher dose; PKN605 lower dose

Placebo OTHER

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• One or more of the following:
• 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 (1 point for congestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack)
• 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
• Participants must have a body mass index (BMI) ≥ 18 kg/m2. BMI is calculated as body weight (kg) divided by height (m) squared
• Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)

You may not qualify if:

• Permanent AF
• 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 anti-arrhythmic 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
• Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used
• Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (38)

Cardiology Associates of North MS

Tupelo, Mississippi, 38801, United States

RECRUITING

Weill Cornell Medical Center

New York, New York, 10021, United States

RECRUITING

Duke Univ Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Swedish Heart and Vascular Clinic

Seattle, Washington, 98122, United States

RECRUITING

Novartis Investigative Site

Calgary, Alberta, T2P 3C5, Canada

RECRUITING

Novartis Investigative Site

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Novartis Investigative Site

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Novartis Investigative Site

London, Ontario, N6A 5W9, Canada

RECRUITING

Novartis Investigative Site

Newmarket, Ontario, L3Y 2P6, Canada

RECRUITING

Novartis Investigative Site

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Novartis Investigative Site

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H2X 1R9, Canada

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Novartis Investigative Site

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Novartis Investigative Site

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Novartis Investigative Site

Beijing, Beijing Municipality, 100013, China

RECRUITING

Novartis Investigative Site

Beijing, 100730, China

RECRUITING

Novartis Investigative Site

Xi'an, 223001, China

RECRUITING

Novartis Investigative Site

Bad Homburg, 61348, Germany

RECRUITING

Novartis Investigative Site

Berlin, 10787, Germany

RECRUITING

Novartis Investigative Site

Berlin, 13353, Germany

RECRUITING

Novartis Investigative Site

Hamburg, 20099, Germany

RECRUITING

Novartis Investigative Site

Hamburg, 20246, Germany

RECRUITING

Novartis Investigative Site

Arnhem, Gelderland, 6815 AD, Netherlands

RECRUITING

Novartis Investigative Site

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Novartis Investigative Site

Delft, South Holland, 2625 AD, Netherlands

RECRUITING

Novartis Investigative Site

Goes, Zeeland, 4462 RA, Netherlands

RECRUITING

Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

RECRUITING

Novartis Investigative Site

Veldhoven, 5504 DB, Netherlands

RECRUITING

Novartis Investigative Site

Singapore, Singapore, S308433, Singapore

RECRUITING

Novartis Investigative Site

Singapore, 119074, Singapore

RECRUITING

Novartis Investigative Site

Singapore, 169609, Singapore

RECRUITING

Novartis Investigative Site

Brighton, East Sussex, BN2 5BE, United Kingdom

RECRUITING

Novartis Investigative Site

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

RECRUITING

Novartis Investigative Site

Liverpool, L14 3PE, United Kingdom

WITHDRAWN

Novartis Investigative Site

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 15, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): September 9, 2027
• Study Completion (Estimated): September 9, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (12); CN (3); NL (6); GB (4); DE (5); SG (3); US (5)