CPKN605A12201: PKN605 in participants with atrial fibrillation
Research type
Research Study
Full title
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
IRAS ID
1011621
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd.
Research summary
The purpose of this study is to learn more about the effects and safety of the study medication PKN605 in people with atrial fibrillation (AFib). AFib is an abnormal heart rhythm, which causes the heart to beat in an irregular way and can come and go. PKN605 is designed to block a protein that plays a role in AFib and by blocking this protein, researchers think PKN605 could return an abnormal heart rhythm to normal.
Researchers will be using ECGs (electrocardiograms) to measure heart rhythm to learn if PKN605 lowers the amount of time people are in AFib. PKN605 is taken by mouth as tablets and has been studied in 2 studies that included 83 healthy participants; however, it has not been studied in participants with AFib.
About 165 participants from 7 countries will take part in the study. Most participants will be in the study for up to 7.5 months (with 10 clinic visits) but some could be in the study for up to 10 months (with 11 clinic visits). Study staff will confirm the length of participation.
A computer program will randomly assign participants to the following treatment groups:
- higher PKN605 dose (2 tablets every morning and evening)
- lower PKN605 dose (2 tablets every morning and evening)
- placebo (2 tablets every morning and evening; placebo looks like the study drug but has no drug in it).
Treatment duration is 24 weeks plus a safety follow up visit approximately 4 weeks after the end of treatment.
Patients in the study may not directly benefit from their participation, but Novartis may learn new information about the disease that
could help treat other patients in the future.
The study is organised/funded by Novartis Pharmaceuticals UK Ltd. and run by medical staff in hospital.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0303
Date of REC Opinion
26 Nov 2025
REC opinion
Further Information Favourable Opinion