Hepatic Impairment Study

October 31, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33014
      • Orlando, Florida, United States, 32809
    • Tennessee
      • Knoxville, Tennessee, United States, 37920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Sorafenib (Nexavar, BAY43-9006)
Mildly Hepatic Impaired Subjects
Drug: Sorafenib (Nexavar, BAY43-9006)
Moderately Hepatic Impaired Subjects
Drug: Sorafenib (Nexavar, BAY43-9006)
Healthy Subjects
Experimental: Arm 2
Drug: Sorafenib (Nexavar, BAY43-9006)
Mildly Hepatic Impaired Subjects
Drug: Sorafenib (Nexavar, BAY43-9006)
Moderately Hepatic Impaired Subjects
Drug: Sorafenib (Nexavar, BAY43-9006)
Healthy Subjects
Experimental: Arm 3
Drug: Sorafenib (Nexavar, BAY43-9006)
Mildly Hepatic Impaired Subjects
Drug: Sorafenib (Nexavar, BAY43-9006)
Moderately Hepatic Impaired Subjects
Drug: Sorafenib (Nexavar, BAY43-9006)
Healthy Subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK measurements
Time Frame: Day 1-6
Day 1-6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2014

Last Update Submitted That Met QC Criteria

October 31, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12349

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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