Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Deferasirox

Criteria

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.