Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00432627
Collaborator
(none)
24
Enrollment
1
Location
4
Arms
44
Duration (Months)
0.5
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Experimental: Mild hepatic impaired

Drug: Deferasirox
one dose of 20 mg/kg/day
Other Names:
  • ICL670
  • Experimental: Moderate hepatic impaired

    Drug: Deferasirox
    one dose of 20 mg/kg/day
    Other Names:
  • ICL670
  • Experimental: Severe hepatic impaired

    Drug: Deferasirox
    one dose of 20 mg/kg/day
    Other Names:
  • ICL670
  • Experimental: Healthy volunteers

    Controlled group

    Drug: Deferasirox
    one dose of 20 mg/kg/day
    Other Names:
  • ICL670
  • Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics of deferasirox and its metabolites [at FPFV and at LPLV]

    Secondary Outcome Measures

    1. Safety and tolerability of deferasirox assessed by adverse events [at FPFV and at LPLV]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    SiteCityStateCountryPostal Code
    1Novartis Investigative SiteKielGermany

    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.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00432627
    Other Study ID Numbers:
    • CICL670A2125
    First Posted:
    Feb 8, 2007
    Last Update Posted:
    Dec 9, 2020
    Last Verified:
    Apr 1, 2016
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 9, 2020