Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males
Status:
Completed
Trial end date:
2014-08-21
Target enrollment:
Participant gender:
Summary
This study is for research purposes only and will not treat any disease or condition you may
have. The study is an open label and single dose study; open label means that you, the study
doctor and study staff will know which study drug you are taking.
The purpose of this research study is to compare drug levels in the body of people with liver
disease to drug levels in healthy people with a normal liver. In addition, the safety of the
study drug will be studied. Information about any side effects (discomfort or decline in
health) that may happen will be collected. The study drug will be given by mouth to subjects
with liver disease and to healthy subjects.
In the body, drugs are normally removed by the liver with a smaller amount being removed by
the kidneys. When the liver is not working as well as it should, the body may not be able to
remove drugs from the body quickly.
The information from this study will be used to decide if the drug is safe in subjects with
liver disease or if a lower dose of the study drug would be safer.