Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
NCT01560143
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Adult Trials: 18+ Years
Subjects fulfilling the following criteria will be eligible:
1. males and females, 18 to 50 years of age;
2. non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;
3. Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);
4. female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period
1. history of significant hypersensitivity reaction to any components of Tygacil®;
2. history of significant clinical illness requiring pharmacological management;
3. history of blood donation in the past eight week period;
4. abnormal serum electrolyte or complete blood count requiring further clinical work-up;
5. transaminases (AST or ALT) > 2.5 x upper limit of normal;
6. subjects with stage 4 or 5 chronic kidney disease;
7. positive serum pregnancy test (if female);
8. abnormal electrocardiogram (ECG) as judged by study physician;
9. unable to tolerate venipuncture and multiple blood draws;
10. clinically significant abnormal physical examination defined as a physical finding
requiring further clinical work-up;
11. unable to independently provide a written informed consent.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects | ||||
| Official Title ICMJE | Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects | ||||
| Brief Summary | If tigecycline clearance increases with body size then serum exposure values will be lower in obese class III compared to normal weight subjects because exposure changes inversely with clearance when the dose is fixed without regard to weight. | ||||
| Detailed Description | Not required | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 4 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Drug: Tigecycline
100 mg IV as a single infusion over 30 minutes Other Name: Tygacil | ||||
| Study Arms ICMJE | Tigecycline
All subjects receive a single dose of tigecycline Intervention: Drug: Tigecycline | ||||
| Publications * | Pai MP. Serum and urine pharmacokinetics of tigecycline in obese class III and normal weight adults. J Antimicrob Chemother. 2014 Jan;69(1):190-9. doi: 10.1093/jac/dkt299. Epub 2013 Jul 23. | ||||
* 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 | 12 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | May 2012 | ||||
| Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Subjects fulfilling the following criteria will be eligible:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years to 50 Years (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 | NCT01560143 | ||||
| Other Study ID Numbers ICMJE | 11-007 WS2001231 ( Other Grant/Funding Number: Pfizer, Inc. ) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement ICMJE |
| ||||
| Responsible Party | Manjunath Prakash Pai, University of Michigan | ||||
| Study Sponsor ICMJE | Manjunath Prakash Pai | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
| ||||
| PRS Account | University of Michigan | ||||
| Verification Date | December 2016 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||