Trial record 1 of 1 for:
NCT00406237
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00406237 |
Recruitment Status :
Completed
First Posted : December 4, 2006
Last Update Posted : April 4, 2011
|
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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 |
To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction. [ Time Frame: 5 days ] | |||
Original Primary Outcome Measures ICMJE |
To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction. | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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 |
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 |
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:
|
|||
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 |