Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of 20 mg/kg Oral Deferasirox in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.

Inclusion criteria for those with hepatic impairment:

• Physical signs consistent with a clinical diagnosis of liver cirrhosis
• Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
• Otherwise considered healthy

Inclusion criteria for healthy volunteers:

• In good health.

Exclusion criteria for those with hepatic impairment:

• Clinically significant abnormal findings other than hepatic impairment
• Clinical evidence of severe ascites
• History of surgical portosystemic shunt
• Any evidence of progressive liver disease within the last 4 weeks

Exclusion criteria for healthy controls:

• Clinical evidence of liver disease or liver injury
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
• Use of any prescription medication within 1 month prior to dosing

Other protocol defined inclusion/exclusion criteria may apply.