Phase 4
Completed N=12
Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Source: ClinicalTrials.gov NCT01560143 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours — 7.64 hour*mg/L
◆ Published Evidence
Established
31citations · ~3 / year
Serum and urine pharmacokinetics of tigecycline in obese class III and normal weight adults.
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.
Linked Publications
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Serum and urine pharmacokinetics of tigecycline in obese class III and normal weight adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours |
7.64 | — |
Eligibility Criteria
Inclusion Criteria
Subjects fulfilling the following criteria will be eligible:
- males and females, 18 to 50 years of age;
- non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;
- Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);
- 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
Exclusion Criteria
- history of significant hypersensitivity reaction to any components of Tygacil®;
- history of significant clinical illness requiring pharmacological management;
- history of blood donation in the past eight week period;
- abnormal serum electrolyte or complete blood count requiring further clinical work-up;
- transaminases (AST or ALT) > 2.5 x upper limit of normal;
- subjects with stage 4 or 5 chronic kidney disease;
- positive serum pregnancy test (if female);
- abnormal electrocardiogram (ECG) as judged by study physician;
- unable to tolerate venipuncture and multiple blood draws;
- clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up;
- unable to independently provide a written informed consent.
Data sourced from ClinicalTrials.gov (NCT01560143) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.