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

Part of paid clinical trials in Tupelo, Mississippi.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07217067
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PKN605 — DRUG
    PKN605 is an oral formulation
  • Placebo — OTHER
    Matching placebo

Study Details

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

Key Dates

Start date
Oct 28, 2025
Status verified
May 2026
Primary completion
Sep 9, 2027
Completion
Sep 9, 2027

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PKN605 lower dose
    PKN605 is an oral formulation
  • Experimental: PKN605 higher dose
    PKN605 is an oral formulation
  • Placebo Comparator: Placebo
    Placebo is an oral formulation

Primary Outcome Measure

Atrial fibrillation burden from ECG patch monitors [ Time Frame: 24 weeks ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
  • Novartis Pharmaceuticals
    +41613241111

Locations (5)

FacilityCityStateZIPSite coordinators
Cardiology Associates of North MSTupeloMississippi38801
Brittany Cook
James Edgar Stone (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CenterNew YorkNew York10021
Penn Collins
Jim Way Cheung (PRINCIPAL_INVESTIGATOR)
Duke Univ Medical CenterDurhamNorth Carolina27710
Jessalyn Davis
Jonathan Piccini (PRINCIPAL_INVESTIGATOR)
Intermountain Medical CenterMurrayUtah84107
Paden Hansen
Michael Cutler (PRINCIPAL_INVESTIGATOR)
Swedish Heart and Vascular ClinicSeattleWashington98122
Serena Risher
+1 206 386 6462
David Lam (PRINCIPAL_INVESTIGATOR)

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