check_circleStudy Completed

Liver Disease

Bayer Identifier:

12349

ClinicalTrials.gov Identifier:

NCT00829231

EudraCT Number:

Not Available

EU CT Number:

Not Available
Hepatic Impairment Study

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.

Key Participants Requirements

Sex

Both

Age

50 - 75 Years
  • - Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.

Trial summary

Enrollment Goal
45
Trial Dates
January 2009 - July 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Clinical Pharmacology of Miami, Inc.Miami, 33014, United States
Completed
Orlando Clinical Research CenterOrlando, 32809, United States
Completed
New Orleans Center for Clinical ResearchKnoxville, 37920, United States

Primary Outcome

  • PK measurements
    date_rangeTime Frame:
    Day 1-6
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Physical Exam
    date_rangeTime Frame:
    Screening, Day 6
    enhanced_encryption
    Safety Issue:
    yes
  • Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis
    date_rangeTime Frame:
    Screening Day 1, Day 6
    enhanced_encryption
    Safety Issue:
    yes
  • ECG
    date_rangeTime Frame:
    Screening Day 1, Day 6
    enhanced_encryption
    Safety Issue:
    yes
  • Vital Signs
    date_rangeTime Frame:
    Screening Day 1, Day 6
    enhanced_encryption
    Safety Issue:
    yes
  • Follow up phone call
    date_rangeTime Frame:
    Day 14
    enhanced_encryption
    Safety Issue:
    yes

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

Additional Information

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