Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00406237

First received: November 29, 2006

Last updated: April 1, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 29, 2006

Last Updated Date

April 1, 2011

Start Date ^ICMJE

December 2006

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction. [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 ^ICMJE

To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Liver Cirrhosis, Biliary

Intervention ^ICMJE

Drug: tigecycline

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

Other Name: Tygacil, GAR-936

Study Arm (s)

Experimental: 1

Intervention: Drug: tigecycline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT Number ^ICMJE

NCT00406237

Other Study ID Numbers ^ICMJE

3074A1-120, B1811005

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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