Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hepatic Impairment Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00829231
First received: January 23, 2009
Last updated: October 31, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Liver Disease
Drug: Sorafenib (Nexavar, BAY43-9006)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • PK measurements [ Time Frame: Day 1-6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physical Exam [ Time Frame: Screening, Day 6 ] [ Designated as safety issue: Yes ]
  • Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis [ Time Frame: Screening Day 1, Day 6 ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Screening Day 1, Day 6 ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Screening Day 1, Day 6 ] [ Designated as safety issue: Yes ]
  • Follow up phone call [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829231

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00829231     History of Changes
Other Study ID Numbers: 12349
Study First Received: January 23, 2009
Last Updated: October 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Liver disease

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Niacinamide
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 23, 2014