Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Minocycline; Tigecycline

Criteria

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.