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Trial record 1 of 1 for:    NCT00406237
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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:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE November 29, 2006
First Posted Date  ICMJE December 4, 2006
Last Update Posted Date April 4, 2011
Study Start Date  ICMJE December 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  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  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: October 7, 2010)
8
Original Enrollment  ICMJE
 (submitted: November 30, 2006)
12
Actual Study Completion Date  ICMJE March 2009
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00406237
Other Study ID Numbers  ICMJE 3074A1-120
B1811005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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