Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males
Condition: Clinical Pharmacology, Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      The study will be conducted at more than one clinical site (2-3 clinical research sites) and
      designed to assess the impact of severe liver disease or hepatic impairment (Part 1, Group 1)
      on the PK of pomalidomide following oral administration of a single dose of 4 mg pomalidomide
      (the study drug). The study drug, pomalidomide (POMALYST®), has been approved by the United
      States Food and Drug Administration (FDA) to treat patients with multiple myeloma (MM).
      Patients with MM have bone marrow that produces a large number of abnormal cells.
      Pomalidomide is only available by prescription.

      Since participants in this study do not have MM, pomalidomide is considered experimental for
      the purposes of this research study. Throughout this form, pomalidomide will be referred to
      as "the study drug."

      Participation in this study will be in either the healthy group or the group with liver
      disease. For the group with the liver disease,the liver disease will be graded by the study
      doctor as being "severe," "moderate," or "mild." This will be done by the study doctor
      depending on medical history, physical examination, laboratory tests, and certain previous
      results of liver scans or liver biopsy.

      The amount of the study drug in blood will be measured at certain times to how well the drug
      is broken-down or removed from the body. Blood samples approximately 1 teaspoon
      (approximately 5-6 mL) will be collected 13 times the following times to measure study drug
      levels in your blood:

      • Predose (just before dosing), and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, and 48 hours
      after dose pomalidomide morning dose on Day 1.

      This study will have two parts:

      Part 1 will evaluate the study drug in subjects with severe liver disease (Group and healthy
      volunteer subjects (Group 1) matched to the subjects with liver disease. Part 2 will evaluate
      the study drug in subjects with moderate (Group 3) and/ mild (Group 4) liver disease.

      Study participation will be in one part only (either Part 1 or Part 2). Part be conducted
      after the data from Part 1 is analyzed and reviewed and the doctor and the sponsor determine
      that there is a need to conduct Part 2.

      The purposes of this study are:

        -  To measure and compare the levels of pomalidomide in the blood of male subjects with
           severe liver disease and their matched healthy volunteer subjects after taking one 4-mg
           capsule of pomalidomide.

        -  To measure and compare the levels of pomalidomide in the blood of male subjects with
           moderate or mild liver disease after taking one 4-mg capsule of pomalidomide.

        -  To study the impact of liver disease on the safety of a single dose of pomalidomide in
           male subjects with liver disease.

      Approximately 16 male subjects will be enrolled in Part 1 of the study (8 healthy subjects
      and 8 subjects with severe liver disease). Approximately 16 male subjects will be in Part 2
      of the study (8 subjects with mild liver disease and subjects with moderate liver disease).
      If both parts of the study are completed, a total of about 32 male subjects will be enrolled.
      The total time a participant will be in the study is about 1 month (from screening visit to
      end of study).
    

Intervention name(s): Pomalidomide; Pomalidomide
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of 4-mg capsule; 4-mg capsule
Other intervention name(s): POMALYST®; POMALYST®
Intervention MeSH terms: Thalidomide; Pomalidomide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hepatic, Liver disease; Pharmacokinetic; Healthy