Trial Condition(s):
Liver Disease
Hepatic Impairment Study
Bayer Identifier:
12349
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
: - Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Clinical Pharmacology of Miami, Inc. Miami, United States, 33014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orlando Clinical Research Center Orlando, United States, 32809 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Orleans Center for Clinical Research Knoxville, United States, 37920 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open Label, Phase 1 to evaluate the effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
3
Primary Outcome
- PK measurementsTimeframe: Day 1-6
Secondary Outcome
- Physical ExamTimeframe: Screening, Day 6
- Labotatory Safety, Chemistry panel, PTT, hematology Urine AnalysisTimeframe: Screening Day 1, Day 6
- ECGTimeframe: Screening Day 1, Day 6
- Vital SignsTimeframe: Screening Day 1, Day 6
- Follow up phone callTimeframe: Day 14
Additional Information
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