Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

Exclusion Criteria

• •Known hypersensitivity to quinolones/fluoroquinolones.
• •Subjects must not fulfill the following criteria:
• •In hepatically impaired patients:
• •Use of prohibited concomitant medication, with the exception of those essential for the management of hepatic impairment and the treatment of concomitant stable medical conditions for the hepatically impaired patients as per the discretion of the Investigator.
• •Fluctuating or rapidly deteriorating hepatic function as indicated by recent history or widely varying or worsening of clinical and/or laboratory signs of hepatic impairment as judged by the Investigator.
• •Concomitant treatment with Interferon or other prohibited medications
• •Active stage 3 and stage 4 encephalopathy OR
• •Healthy Volunteers:
• •Use of any concomitant medication within 7 days from the screening except those deemed safe for the study by the Investigator and Medical Monitor.
• •History of any clinically significant chronic and/or active hepatic disease including elevations of serum transaminases including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \[except those which are considered non-significant by the Investigator; however, these should not exceed 1.5 times the Upper Limit of Normal (ULN)\], hepatitis (Hepatitis A, B or C), biliary tract disease, or history of any significant gastrointestinal surgery.