Hepatic Impairment Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00829231
First received: January 23, 2009
Last updated: October 28, 2013
Last verified: October 2013

January 23, 2009
October 28, 2013
January 2009
July 2009   (final data collection date for primary outcome measure)
PK measurements [ Time Frame: Day 1-6 ] [ Designated as safety issue: Yes ]
Pharmacokinetic measurements [ Time Frame: Day 1-6 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00829231 on ClinicalTrials.gov Archive Site
  • Physical Exam [ Time Frame: Screening, Day 6 ] [ Designated as safety issue: Yes ]
  • Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis [ Time Frame: Screening Day 1, Day 6 ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Screening Day 1, Day 6 ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Screening Day 1, Day 6 ] [ Designated as safety issue: Yes ]
  • Follow up phone call [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
  • Physical Exam [ Time Frame: Screening, Day 6 ] [ Designated as safety issue: Yes ]
  • Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis [ Time Frame: Screening Day 1, Day 6 ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Screening Day 1, Day 6 ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Screening Day 1, Day 6 ] [ Designated as safety issue: Yes ]
  • Follow up phone call [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Hepatic Impairment Study
Open Label, Phase 1 to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)

This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. Subjects with varying degrees of liver function are being asked to participate in this study. Study results from subjects with normal liver function will be compared with study results from subjects with impaired liver function.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Disease
  • Drug: Sorafenib (Nexavar, BAY43-9006)
    Mildly Hepatic Impaired Subjects
  • Drug: Sorafenib (Nexavar, BAY43-9006)
    Moderately Hepatic Impaired Subjects
  • Drug: Sorafenib (Nexavar, BAY43-9006)
    Healthy Subjects
  • Experimental: Arm 1
    Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
  • Experimental: Arm 2
    Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
  • Experimental: Arm 3
    Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.
Both
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829231
12349
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP