Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: November 29, 2006
• First Posted Date: December 4, 2006
• Last Update Posted Date: April 4, 2011
• Study Start Date: December 2006
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 21, 2007): To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction. [ Time Frame: 5 days ]
• Original Primary Outcome Measures (submitted: November 30, 2006): To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction.
• Change History: Complete list of historical versions of study NCT00406237 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: December 21, 2007): To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction. [ Time Frame: 15 days ]
• Original Secondary Outcome Measures (submitted: November 30, 2006): To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
• Official Title: Open Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)
• Condition: Liver Cirrhosis, Biliary

Intervention

Drug: tigecycline

Single intravenous dose of tigecycline 50 mg, as a 30-minute infusion

Other Name: Tygacil, GAR-936

Study Arms

Experimental: 1

Intervention: Drug: tigecycline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 7, 2010): 8
• Original Enrollment (submitted: November 30, 2006): 12
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT00406237
• Other Study ID Numbers: 3074A1-120; B1811005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: April 2011