Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

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NCT00406237

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Study Location
Pfizer Investigational Site
St. Paul, Minnesota, 55114, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Biliary Liver Cirrhosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Biliary Liver CirrhosisPharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis NCT00406237
  1. St. Paul, Minnesota
  2. Durham, North Carolina
  3. Santurce,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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