Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
NCT00406237
ABOUT THIS STUDY
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- 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).
- 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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Descriptive Information | ||||
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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 | 8 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 |
| |||
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 |