- Healthy:Matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per
- Subjects with hepatic disease: 1. mild impairment (child-pugh score 5-6), moderate
(child-pugh score 7-9). 2. stable hepatic disease: no changes in the last 30 days. 3.
stable dose of medication and/or treatment.
- All subjects: Non-prescribed use of drugs of abuse/recreational drugs; recent
treatment with experimental drugs or herbal experiments; ECG and blood pressure
falling outside of protocol-specified limits; history of regular tobacco use exceeding
- Normal subjects: medically important health conditions; recent use of prescription or
non-prescription medications; history of regular alcohol use exceeding
- Subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and
hepatorenal syndrome;Undergone porta-caval shunt surgery; History of GI hemorrhage due
to esophageal varices or peptic ulcers less than 1 month prior to study entry;
significant hepatic encephalopathy; severe ascites and/or pleural effusion; Positive
blood alcohol test/alcohol breathalyzer at screening or on Day 0.