This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone in subjects with mild or moderate hepatic impairment comparatively to healthy matched subjects

Inclusion Criteria:

• Inclusion criteria (all subjects):
• Caucasian subjects
• Inclusion criteria (hepatic impaired subjects):
• subjects with physical signs consistent with a clinical diagnosis of stable liver disease, which has been confirmed by imaging techniques, ultrasound, Magnetic Resonance Imaging or Computed Tomogram within 3 months of screening, and a creatinine clearance > 50 mL/min (based on Cockroft and Gault formula).
• Inclusion criteria (healthy volunteers):
• good general health
• matched by age, gender, smoking status, Body Mass Index, and CYP2D6 phenotype to hepatic impaired subjects.

Exclusion Criteria:

• Exclusion criteria (all subjects):
• Subjects who report smoking a pipe, cigars or more than 20 cigarettes per day .
• History of drug abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening
• History of first-dose response/syncope to alpha1-blocking agents
• Exclusion criteria (Hepatic impaired subjects):
• Patients with symptoms or 6 months past history of encephalopathy.
• Patients with clinical evidence of moderate-severe ascites.
• Patients having a previous surgical porto-systemic shunt.
• Exclusion criteria (Healthy volunteers):
• History of alcohol abuse prior to dosing, or evidence of such abuse during screening.
• Pulse Rate > 200 msec

Other protocol-defined inclusion/exclusion criteria may apply