Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function

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.