PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers

Exclusion Criteria

• •All Subjects:
• •Known infection with human immunodeficiency virus (HIV) upon serological testing
• •Evidence of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, renal, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
• •Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product (e.g., inflammatory bowel disease, resections of the small or large intestine, etc.)
• •History of febrile illness within 5 days prior to dosing Note: Subjects can be rescreened once afebrile and more than 5 days have elapsed since the febrile illness.
• •Known ongoing drug abuse within one month prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during Screening and/or at Day -1
• •Subjects with active or history of malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
• •Dosing in another clinical trial within 30 days prior to the study drug administration
• •If female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
• •Matched Healthy Volunteers:
• •Evidence of clinically significant liver disease or liver damage (e.g., hepatitis B or C, autoimmune hepatitis, primary biliary cirrhosis, non-alcoholic fatty liver disease, elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is considered clinically significant by the Investigator, etc.)
• •Screening creatinine clearance \<80 mL/min using the Cockcroft-Gault equation
• •History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of \>450 milliseconds (msec)
• •History of regular alcohol consumption exceeding 28 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of spirits) within 6 months of Screening
• •Subjects with Hepatic Impairment:
• •Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment during Screening period and up to Day -1 (e.g., advanced ascites, infection of ascites, fever, active gastrointestinal bleeding)
• •History of liver transplant, or have a transjugular intrahepatic portosystemic shunt, and/or have undergone portacaval shunting
• •History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of \>480 milliseconds (msec)
• •Screening creatinine clearance \<50 mL/min using the Cockcroft-Gault equation