The study will assess the PK, tolerability, and safety of oral trimetazidine administered to subjects with acute-on-chronic (ACLF) Grades 1 and 2 with liver failure and a range of renal function. Subjects will receive up to 60 mg/day for 28 days.~Two groups of subjects will be enrolled:~Group 1~AD with serum creatinine ≥ 1 and < 2 mg/dL, OR~ACLF 1 with~liver failure and serum creatinine ≥ 1.5 and < 2 mg/dl, or~liver failure and West Haven grade 1-2 hepatic encephalopathy, or~coagulation failure and serum creatinine ≥ 1.5 and < 2 mg/dl, or~coagulation failure and West Haven grade 1-2 hepatic encephalopathy, OR~ACLF 2 with~liver failure and coagulation failure, or~liver failure and West Haven grade 3-4 hepatic encephalopathy.~Group 2~ACLF 1 with renal failure (serum creatinine ≥ 2.0 and < 3.5 mg/dL), OR~ACLF 2 with~liver failure and renal failure (serum creatinine ≥ 2.0 and < 3.5 mg/dL), or~coagulation failure and renal failure (serum creatinine ≥ 2.0 and < 3.5 mg/dL).
The study will assess the pharmacokinetics (PK), tolerability, and safety of oral trimetazidine administered to subjects with AD (ACLF Grade 0) or with ACLF Grade 1 or 2.