Status:
COMPLETED
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Liver Cirrhosis, Biliary
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)
Detailed Description
pharmacokinetic study
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00406237
Start Date
December 1 2006
End Date
March 1 2009
Last Update
April 4 2011
Active Locations (3)
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1
Pfizer Investigational Site
Saint Paul, Minnesota, United States, 55114
2
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
3
Pfizer Investigational Site
Santurce, Puerto Rico, Puerto Rico, 00909