Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Manjunath Prakash Pai
• Collaborator: Pfizer
• Treatments: Minocycline; Tigecycline

Criteria

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.