Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone
NCT00376324
Last updated date
ABOUT THIS STUDY
Study to examine the concentration of the study drug, tigecycline, in human bone samples
following the administration of multiple doses.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
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1-800-718-1021
Eligibility Criteria
condition
Healthy Subjects
Sex
Females and Males
Age
18 + years
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
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 ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
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. | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Bhattacharya I, Gotfried MH, Ji AJ, Saunders JP, Gourley I, Diehl A, Korth-Bradley JM. Reassessment of tigecycline bone concentrations in volunteers undergoing elective orthopedic procedures. J Clin Pharmacol. 2014 Jan;54(1):70-4. doi: 10.1002/jcph.201. Epub 2013 Oct 24. | |||
* 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 | |||
Estimated Enrollment ICMJE | 36 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2008 | |||
Actual Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion:
Exclusion:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | 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 ICMJE | 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 |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | July 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |