Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

Not required

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.