Pharmacokinetics of Voriconazole in Obese Subjects

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Obese subjects may require a higher fixed oral maintenance dosing regimen of voriconazole compared to normal weight subjects to achieve comparable plasma exposures. The current study is designed to address this issue.

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

Details

• Lead Sponsor: Albany College of Pharmacy and Health Sciences; Manjunath Prakash Pai
• Collaborators: Pfizer; TKL Research, Inc.
• Treatments: Voriconazole

Criteria

Inclusion Criteria:

1. males and females, 18 to 50 years of age;

2. non-smoking or light-smoking (≤5 cigarettes per day) volunteers;

3. BMI ≥ 35 kg/m2;

4. female subjects of childbearing potential 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 week following the study period.

Exclusion Criteria:

1. History of significant hypersensitivity reaction or intolerance to voriconazole, fluconazole,itraconazole, posaconazole, or ketoconazole ;

2. history of significant clinical illness requiring pharmacological management;

3. abnormal serum electrolyte or complete blood count requiring further clinical work-up;

4. transaminases (AST or ALT) >2.5 x upper limit of normal;

5. estimated creatinine clearance <50 mL/min (Cockcroft-Gault equation);

6. positive urine pregnancy test (if female);

7. abnormal electrocardiogram (ECG) as judged by study physician;

8. unable to tolerate venipuncture and multiple blood draws;

9. clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up.