Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Intervention: SSP-004184
Intervention description: All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is
      absorbed by the body and how long it takes to be eliminated from the body in healthy subjects
      and subjects with mild, moderate, and severe hepatic (liver) impairment compared with
      subjects with healthy normal liver function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years inclusive at the time of consent.

          -  Willingness to comply with any applicable contraceptive requirements of the protocol
             and is:

          -  Male, or

          -  Non pregnant, non lactating female

          -  Females must be at least 90 days post partum or nulliparous.

        Subjects who do not have hepatic impairment (healthy subjects)

          -  Normal renal function.

        Subjects with hepatic impairment

          -  Subjects must provide a letter of evaluation from a hepatologist or copy of supporting
             documents confirming the subject's hepatic impairment (a liver biopsy is preferable
             but not mandatory).

          -  Hepatic impairment should be primary and must not be a complication of an underlying
             primary systemic disease (eg, patients with metastatic cancer and cancer cachexia)

          -  Documented chronic stable liver impairment

        Exclusion Criteria

        Subjects who do not have hepatic impairment (healthy subjects)

          -  A positive HIV antibody screen, Hepatitis B surface antigen, or Hepatitis C virus
             antibody screen.

        Subjects with hepatic impairment

          -  Presence of a hepatocellular carcinoma, or an acute hepatic disease caused by an
             infection or drug toxicity.

          -  Presence of surgically created or transjugular intrahepatic portal systemic shunts.

          -  A positive HIV antibody screen.

          -  Renal insufficiency.

        All subjects

          -  Subject has a history of thyroid disorder.

          -  History of nephrotic syndrome.

          -  History of alcohol or other substance abuse within the last year.

          -  A positive screen for alcohol or drugs of abuse.

          -  Male subjects who consume more than 3 units of alcohol per day. Female subjects who
             consume more than 2 units of alcohol per day. (1 alcohol unit = 1 beer [12 oz/355 mL]
             = 1 wine [5 oz/150 mL] = 1 liquor [1.5 oz/40 mL] = 0.75 oz/20 mL alcohol.)

          -  Caffeine consumption: For healthy subjects: Routine consumption of more than 2 units
             of caffeine per day or subjects who experience caffeine withdrawal headaches or have a
             history of caffeine withdrawal headaches. (One caffeine unit is contained in the
             following items: one 6 oz/180 mL cup of coffee, two 12 oz/355 mL (ie, 24 oz/710 mL
             cola) cans of cola, one 12 oz/355 mL cup of tea, three 1 oz/28 g chocolate bars (ie, 3
             oz/85 g chocolate). Decaffeinated coffee, tea, or cola are not considered to contain
             caffeine.)

          -  Donation of blood or blood products within 60 days.

          -  Substantial changes in eating habits within 30 days.