Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy

Exclusion Criteria14

• NYHA class IV heart failure
• Ventricular scar secondary to coronary artery disease
• Initiation, cessation, or dose change of a Class I or III anti-arrhythmic drug in the 3 months prior to screening
• Any potentially harmful chronic liver disease
• ALT value \> 2X the upper limit of the normal reference range at Screening
• Total bilirubin value greater than the upper limit of the normal reference range at Screening, unless documented Gilbert's syndrome. For individuals with Gilbert's syndrome, total bilirubin value greater than 2-fold the upper limit of the normal reference range at Screening.
• A history of alcohol or illicit substance use disorders
• Regular and long-term use of strong CYP3A4 inhibitors, including clarithromycin, telithromycin, ketoconazole, itraconazole, posaconazole, nefazodone, idinavir and ritonavir
• Serum creatinine \> 150 micromole/L or creatinine clearance ≤ 60 mL/min (according to Cockcroft-Gault formula) at Screening
• Pregnant at time of enrollment and women of childbearing age who do not use a highly effective form of contraception
• Males, engaged in sexual relations with a female of child-bearing potential, not using an acceptable contraceptive method if not surgically sterile
• Patients unwilling to provide informed consent or comply with follow-up
• Hypersensitivity to tideglusib or any components of its formulation, including allergy to strawberry
• Concurrent use of drugs metabolized by CYP3A4 with a narrow therapeutic window e.g. warfarin and digoxin