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OpenTrials
Completed

NCT Number: NCT00829231

Hepatic Impairment Study

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.

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Key information

Conditions

Liver Disease Digestive System Diseases Liver Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Mildly Hepatic Impaired Subjects

Primary outcomes

  1. PK measurements

    Time frame: Day 1-6

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 26, 2009
Registry last updated
Nov 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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