Pharmacokinetics of Voriconazole in Obese Subjects
Completed · Phase 4
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01030653
- Run by
- Manjunath Prakash Pai
- People needed
- 10
- Starts
- 2009-11-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2017-02-09
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- males and females, 18 to 50 years of age;
- non-smoking or light-smoking (≤5 cigarettes per day) volunteers;
- BMI ≥ 35 kg/m2;
- 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.
You may not qualify if…
- History of significant hypersensitivity reaction or intolerance to voriconazole, fluconazole,itraconazole, posaconazole, or ketoconazole ;
- history of significant clinical illness requiring pharmacological management;
- abnormal serum electrolyte or complete blood count requiring further clinical work-up;
- transaminases (AST or ALT) >2.5 x upper limit of normal;
- estimated creatinine clearance <50 mL/min (Cockcroft-Gault equation);
- positive urine 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.
Where it is running
- TKL Research Inc — Paramus, New Jersey, United States
Full record on ClinicalTrials.gov
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