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Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

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NCT00406237

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
St. Paul, Minnesota, 55114 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT00406237
Pfizer
Completed
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

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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
Intervention Model: Single Group Assignment
Masking: None (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00406237
3074A1-120
B1811005
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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