Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
Study Details
Study Description
Brief Summary
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Mild hepatic impaired
|
Drug: Deferasirox
one dose of 20 mg/kg/day
Other Names:
|
Experimental: Moderate hepatic impaired
|
Drug: Deferasirox
one dose of 20 mg/kg/day
Other Names:
|
Experimental: Severe hepatic impaired
|
Drug: Deferasirox
one dose of 20 mg/kg/day
Other Names:
|
Experimental: Healthy volunteers Controlled group |
Drug: Deferasirox
one dose of 20 mg/kg/day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics of deferasirox and its metabolites [at FPFV and at LPLV]
Secondary Outcome Measures
- Safety and tolerability of deferasirox assessed by adverse events [at FPFV and at LPLV]
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis Investigative Site | Kiel | Germany |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmeceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CICL670A2125