Hepatic Impairment Study

Phase 1

Completed

• Conditions: Liver Disease
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT00829231
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-31
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Sorafenib (Nexavar, BAY43-9006)	-
Arm 2	Sorafenib (Nexavar, BAY43-9006)	-
Arm 3	Sorafenib (Nexavar, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
PK measurements	Day 1-6

Secondary Outcome Measures

Name	Time	Method
Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis	Screening Day 1, Day 6
Physical Exam	Screening, Day 6
ECG	Screening Day 1, Day 6
Follow up phone call	Day 14
Vital Signs	Screening Day 1, Day 6