Hepatic Impairment Study

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829231
• Other study ID #: 12349
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2009
• Last updated: October 31, 2014
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Mildly Hepatic Impaired Subjects
• Sorafenib (Nexavar, BAY43-9006)
Moderately Hepatic Impaired Subjects
• Sorafenib (Nexavar, BAY43-9006)
Healthy Subjects

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK measurements		Day 1-6	Yes
Secondary	Physical Exam		Screening, Day 6	Yes
Secondary	Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis		Screening Day 1, Day 6	Yes
Secondary	ECG		Screening Day 1, Day 6	Yes
Secondary	Vital Signs		Screening Day 1, Day 6	Yes
Secondary	Follow up phone call		Day 14	Yes

External Links

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