Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Open Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)

pharmacokinetic study

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.