Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Completed · Phase 1

Conditions studied: Liver Cirrhosis, Biliary

In brief

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

Key facts

Study ID

NCT00406237

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

8

Starts

2006-12-01

Expected to finish

2009-03-01

Last updated by the study team

2011-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Saint Paul, Minnesota, United States
• Pfizer Investigational Site — Durham, North Carolina, United States
• Pfizer Investigational Site — Santurce, Puerto Rico, Puerto Rico

Full record on ClinicalTrials.gov

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