Back to resultsHepatic Impairment Study
Primary Purpose
Liver Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006)
Sponsored by
About this trial
This is an interventional treatment trial for Liver Disease focused on measuring Liver disease
Eligibility Criteria
Inclusion Criteria:
- Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Outcomes
Primary Outcome Measures
PK measurements
Secondary Outcome Measures
Physical Exam
Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis
ECG
Vital Signs
Follow up phone call
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00829231
Brief Title
Hepatic Impairment Study
Official Title
Open Label, Phase 1 to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
Liver disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar, BAY43-9006)
Intervention Description
Mildly Hepatic Impaired Subjects
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar, BAY43-9006)
Intervention Description
Moderately Hepatic Impaired Subjects
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar, BAY43-9006)
Intervention Description
Healthy Subjects
Primary Outcome Measure Information:
Title
PK measurements
Time Frame
Day 1-6
Secondary Outcome Measure Information:
Title
Physical Exam
Time Frame
Screening, Day 6
Title
Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis
Time Frame
Screening Day 1, Day 6
Title
ECG
Time Frame
Screening Day 1, Day 6
Title
Vital Signs
Time Frame
Screening Day 1, Day 6
Title
Follow up phone call
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
12. IPD Sharing Statement
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Hepatic Impairment Study
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