Study to examine the concentration of the study drug, tigecycline, in human bone samples following the administration of multiple doses.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center
| Descriptive Information | ||||
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| Brief Title ICMJE | Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone | |||
| Official Title ICMJE | An Open-Label, Multiple-Dose Study of the Pharmacokinetics of Tigecycline in Human Bone | |||
| Brief Summary | Study to examine the concentration of the study drug, tigecycline, in human bone samples following the administration of multiple doses. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Healthy Subjects | |||
| Intervention ICMJE | Drug: Tigecycline
Each subject will receive 3 IV doses of tigecycline, as 30-minute infusions: Dose 1 = 100 mgDose 2 = 50 mgDose 3 = 50 mg The doses of tigecycline will be administered to the subjects at approximately 12-hour intervals.
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| Study Arms | Not Provided | |||
| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Estimated Enrollment ICMJE | 36 | |||
| Completion Date | October 2008 | |||
| Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE |
Inclusion:
Exclusion:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00376324 | |||
| Other Study ID Numbers ICMJE | 3074A1-119 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | July 2009 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
