Pharmacokinetics of mitiperstat in participants with hepatic impairment

Exclusion Criteria

• - Any positive result on screening for serum or plasma hepatitis B surface antigen, hepatitis C antibody, and HIV.
• - History of substance dependence or a positive screen for drugs of abuse, likely to impact participant safety or compliance with study procedures.
• - History of alcohol abuse or excessive intake of alcohol in the last 12 months.
• - Abnormal vital signs, after 10 minutes supine rest at screening or Day -1.
• - Any clinically important abnormalities in rhythm, conduction or morphology of the resting 12-lead ECG at screening or Day -1:
• - Vulnerable participants.
• - For female participants only: currently pregnant or breast-feeding.
• Participants with hepatic impairment only
• - Participants with previous transjugular intrahepatic portosystemic shunt (TIPS).
• - Severe ascites defined as ascites requiring paracentesis and albumin at 4-week intervals or less.
• - Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period.
• - Any evidence of additional severe or uncontrolled systemic disease or laboratory finding that makes it unsafe for the participant to participate in the study.
• - Change in dose regimen of medically-required medication within the last 2 weeks before pre-study examination.
• - Biliary obstruction or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver.
• - Clinically relevant hepatic encephalopathy.
• - Oesophageal variceal bleeding in prior 3 months.
• - Platelet count < 50 × 109/L and/or neutrophil count < 1.2 × 109/L and/or haemoglobin < 85 g/L.
• - Post liver transplantation.
• - History of acute or chronic pancreatitis, or pancreatic amylase or lipase greater than twice the ULN at screening.