Liver Cirrhosis, Biliary
Conditions
Brief summary
Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)
Detailed description
pharmacokinetic study
Interventions
DRUGtigecycline
Single intravenous dose of tigecycline 50 mg, as a 30-minute infusion
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction. | 5 days |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction. | 15 days |
Countries
Puerto Rico, United States
Outcome results
None listed