A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment

This study will look at the effect of a single does of study medication in three groups. Each group will have 6 - 8 subjects with similar levels of hepatic impairment. Group 1 will have normal hepatic function. Groups 2 and 3 will be made up of subjects with mild to moderate hepatic impairment. Subjects will have blood taken at specific intervals to measure study medication levels. Subject participation will last approximately 7 to 9 days.

Inclusion criteria

A total of 18 to 24 subjects will be studied in 3 groups of 6-8 subjects per group. Group 1 will consist of 6-8 males or females with normal hepatic function, 18 to 65 years of age inclusive. Groups 2-3 will consist of 6-8 males or females per group with varying degree of stable hepatic impairment.

Exclusion criteria

Any Subject meeting the following criteria must be excluded from the trial:

• Known history of clinically significant arrhythmias.
• Acute illness, especially any infection, within 2 weeks of dosing.
• History or presence of:

• Alcoholism or drug abuse within the past 2 years.
• Hypersensitivity or idiosyncratic reaction to compounds related to the study drug or related compounds.
• Any History of Bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.
• Blood donation or significant blood loss within 56 days prior to Day 1.
• Plasma donation within 7 days prior to Day 1.
• Any subject who has participated in a previous clinical trial with VI-0521.
• Any subject who received an investigational drug within 30 days prior to dosing in this study.
• Any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure.
• Serum creatinine > 1.5 for male subjects, and >1.4 for female subjects.
• History of kidney stones in the last 6 months
• Female subjects, who may be pregnant, or are lactating.
• Use of any drug that is known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism.
• Use of tobacco or nicotine products within last 6 months unless subject is hepatically-impaired.