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
  Purpose

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


Condition Intervention Phase
Liver Cirrhosis, Biliary
Drug: tigecycline
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Open Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: December 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tigecycline
Single intravenous dose of tigecycline 50 mg, as a 30-minute infusion
Other Name: Tygacil, GAR-936

Detailed Description:

pharmacokinetic study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00406237     History of Changes
Other Study ID Numbers: 3074A1-120, B1811005
Study First Received: November 29, 2006
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014