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Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

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ClinicalTrials.gov Identifier: NCT00406237
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : April 4, 2011
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Liver Cirrhosis, Biliary Drug: tigecycline Phase 1

Detailed Description:
pharmacokinetic study

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Open Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
Study Start Date : December 2006
Primary Completion Date : March 2009
Study Completion Date : March 2009


Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: tigecycline
Single intravenous dose of tigecycline 50 mg, as a 30-minute infusion
Other Name: Tygacil, GAR-936


Outcome Measures

Primary Outcome Measures :
  1. To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction. [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction. [ Time Frame: 15 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406237


Locations
United States, Minnesota
Pfizer Investigational Site
St. Paul, Minnesota, United States, 55114
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
Puerto Rico
Pfizer Investigational Site
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00406237     History of Changes
Other Study ID Numbers: 3074A1-120
B1811005
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: April 4, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Liver Cirrhosis, Biliary
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents