Hepatic Impairment Study

Open Label, Phase 1 to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00829231

Enrollment

Registered

2009-01-26

Start date

2009-01-31

Completion date

2009-07-31

Last updated

2014-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease

Keywords

Liver disease

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.

Interventions

DRUGSorafenib (Nexavar, BAY43-9006)

Mildly Hepatic Impaired Subjects

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
PK measurements	Day 1-6

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026