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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520518-79-00

Acronym

CPKN605A12201

Enrollment

Registered

2025-11-17

Start date

2026-01-06

Completion date

Unknown

Last updated

2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

AFB from ECG patch monitors, defined as the amount of time spent in AF as a proportion of the analyzable monitoring time

Detailed description

Time (d) from the date of randomization to first AF recurrence and presence (or absence) of AF recurrence after randomization detected by ECG patch monitor, 12-lead ECG, handheld ECG, or other protocol-approved method for ascertainment, Adverse events, vital signs, 12-lead ECG parameters (including QTcF), and laboratory assessments, PKN605 plasma concentrations; Ctrough (pre-dose), C2h, C4h

Interventions

DRUGPKN605

DRUGPlacebo to PKN605 50 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
AFB from ECG patch monitors, defined as the amount of time spent in AF as a proportion of the analyzable monitoring time	—

Secondary

Measure	Time frame
Time (d) from the date of randomization to first AF recurrence and presence (or absence) of AF recurrence after randomization detected by ECG patch monitor, 12-lead ECG, handheld ECG, or other protocol-approved method for ascertainment, Adverse events, vital signs, 12-lead ECG parameters (including QTcF), and laboratory assessments, PKN605 plasma concentrations; Ctrough (pre-dose), C2h, C4h	—

Countries

Germany, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026