Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function

Exclusion Criteria

• •Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.
• •Subjects with additional active malignant disease within the last five years (with the exception of non-melanoma skin cancers that were not metastatic and have been treated curatively).
• •Subjects with abnormal clinical laboratory values (except the clinical laboratory values linked to hepatic dysfunction).
• •Any surgical or medical condition that may interfere with the conduct of the study, may jeopardize the subject in case of participation in the study or may significantly alter the absorption, distribution, metabolism or excretion of drugs.
• •History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
• •Female subjects who are pregnant (positive pregnancy test at screening or at baseline) or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.
• •Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests.
• •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (antibody positive subjects will be allowed if non-viremic).
• •Symptoms or history of encephalopathy (Stage III or worse) within three months prior to dosing.
• •Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.
• •Subjects with additional active malignant disease within the last five years (with the exception of non-melanoma skin cancers that were not metastatic and have been treated curatively).
• •Subjects with abnormal clinical laboratory values (except the clinical laboratory values linked to hepatic dysfunction).
• •Any surgical or medical condition that may interfere with the conduct of the study, may jeopardize the subject in case of participation in the study or may significantly alter the absorption, distribution, metabolism or excretion of drugs.
• •History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
• •Female subjects who are pregnant (positive pregnancy test at screening or at baseline) or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.
• •Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests.
• •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (antibody positive subjects will be allowed if non-viremic).
• •Symptoms or history of encephalopathy (Stage III or worse) within three months prior to dosing.
• •Clinical evidence of severe ascites.