Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

Manjunath Prakash Pai

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: Tigecycline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01560143

WS2001231 (Other Grant/Funding Number)

11-007

Details and patient eligibility

About

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.

Full description

Not required

Enrollment: 12 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.

Trial design

12 participants in 1 patient group

Tigecycline

Other group

Description:

All subjects receive a single dose of tigecycline

Treatment:

Drug: Tigecycline