ABOUT THIS STUDY
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.
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.
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