Explorative Study of AZD1305 in Atrial Fibrillation Patients

A Randomised, Placebo-controlled, Double-blind, Parallel-group, Multicentre, Phase IIa Study to Explore the Relationship Between QTcF Interval at First Dose (Loading Dose) and at Steady State After Treatment With AZD1305 Extended-release Tablets or Placebo When Given to Patients With Documented AF

Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state

Inclusion Criteria:

• Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
• Sinus rhythm at randomisation

Exclusion Criteria:

• Haemodynamically unstable condition as judged by the Investigator, systolic BP <100 mmHg or >180 mmHg, or diastolic BP >105 mmHg at randomisation
• Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome
• Sinus bradycardia (<50 beats per minute (bpm)) at randomisation
• QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,
• Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
• QRS duration >120 ms at randomisation
• Use of any antiarrhythmic drug class I and/or III, digitalis glycoside, QT prolonging drug and/or drug that inhibits CYP3A4, as well as St John's Worth