Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
- Registration Number
- NCT00406237
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)
- Detailed Description
pharmacokinetic study
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 tigecycline -
- Primary Outcome Measures
Name Time Method To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction. 5 days
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction. 15 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇵🇷Santurce, Puerto Rico