Hepatic Impairment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00829231
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : November 3, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Liver Disease Drug: Sorafenib (Nexavar, BAY43-9006) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Phase 1 to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)
Study Start Date : January 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Experimental: Arm 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Mildly Hepatic Impaired Subjects

Experimental: Arm 2 Drug: Sorafenib (Nexavar, BAY43-9006)
Moderately Hepatic Impaired Subjects

Experimental: Arm 3 Drug: Sorafenib (Nexavar, BAY43-9006)
Healthy Subjects

Primary Outcome Measures :
  1. PK measurements [ Time Frame: Day 1-6 ]

Secondary Outcome Measures :
  1. Physical Exam [ Time Frame: Screening, Day 6 ]
  2. Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis [ Time Frame: Screening Day 1, Day 6 ]
  3. ECG [ Time Frame: Screening Day 1, Day 6 ]
  4. Vital Signs [ Time Frame: Screening Day 1, Day 6 ]
  5. Follow up phone call [ Time Frame: Day 14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00829231

United States, Florida
Miami, Florida, United States, 33014
Orlando, Florida, United States, 32809
United States, Tennessee
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00829231     History of Changes
Other Study ID Numbers: 12349
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

Keywords provided by Bayer:
Liver disease

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs