Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Phase 1

Completed

• Conditions: Liver Cirrhosis, Biliary
• Interventions: Drug: tigecycline

• 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

Study Timeline

• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-30
• Study Start: 2006-12
• Study First Posted: 2006-12-04
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-01
• Last Update Posted: 2011-04-04

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