- Men and nonlactating and nonpregnant women greater than or equal to 18 years of age
- Subjects with biopsy proven primary biliary cirrhosis (PBC) disease in the
asymptomatic or symptomatic phase of PBC.
- Otherwise healthy as determined by the investigator on the basis of medical history,
physical examination, clinical laboratory test results (other than those associated
with PBC), vital signs, and 12-lead electrocardiogram (ECG).
- Subjects with a recent increase in bilirubin, bilirubin >15 mg/dL, presence of
ascites, esophageal varices, or hepatic encephalopathy.
- Any major illness that in the investigator's judgment will substantially increase the
risk associated with the subject's participation in the study
- Any malignancy including hepatocellular carcinoma.