Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
progressive familial intrahepatic cholestasis
MedlinePlus related topics:
Cirrhosis
Drug Information available for:
Tigecycline
U.S. FDA Resources
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
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 May 21, 2013