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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

November 29, 2006
April 1, 2011
December 2006
March 2009   (final data collection date for primary outcome measure)
To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction.
Complete list of historical versions of study NCT00406237 on ClinicalTrials.gov Archive Site
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 ]
To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction.
Not Provided
Not Provided
 
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
Open Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)

pharmacokinetic study

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Liver Cirrhosis, Biliary
Drug: tigecycline
Single intravenous dose of tigecycline 50 mg, as a 30-minute infusion
Other Name: Tygacil, GAR-936
Experimental: 1
Intervention: Drug: tigecycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00406237
3074A1-120, B1811005
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2011

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