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

Exclusion Criteria

• •Any Subject meeting the following criteria must be excluded from the trial:
• •1. Known history of clinically significant arrhythmias.
• •2. Acute illness, especially any infection, within 2 weeks of dosing.
• •3. 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.
• •4. Any History of Bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.
• •5. Blood donation or significant blood loss within 56 days prior to Day 1.
• •6. Plasma donation within 7 days prior to Day 1.
• •7. Any subject who has participated in a previous clinical trial with VI-0521.
• •8. Any subject who received an investigational drug within 30 days prior to dosing in this study.
• •9. Any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure.
• •10. Serum creatinine \> 1.5 for male subjects, and \>1.4 for female subjects.
• •11. History of kidney stones in the last 6 months
• •12. Female subjects, who may be pregnant, or are lactating.
• •13. Use of any drug that is known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism.
• •14. Use of tobacco or nicotine products within last 6 months unless subject is hepatically-impaired.