Hepatic Impairment Study

Bayer

Status and phase: Completed; Phase 1

Conditions: Liver Disease

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00829231

12349

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Arm 1

Experimental group

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Sorafenib (Nexavar, BAY43-9006)

Arm 2

Experimental group

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Sorafenib (Nexavar, BAY43-9006)

Arm 3

Experimental group

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Sorafenib (Nexavar, BAY43-9006)