Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Tigecycline	Tigecycline	All subjects receive a single dose of tigecycline

Primary Outcome Measures

Name	Time	Method
Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours	4 days (96 hours)	The AUC is the area under the concentration time curve in serum measured in the unit of concentration in milligram of tigeycline per liter of plasma multiplied by the time interval in hours (hour\*mg/L)

Secondary Outcome Measures