Phase 4
N=8
Pharmacokinetics of Voriconazole in Obese Subjects
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01030653 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Steady-State Cmax and Cmin of Two Voriconazole Dosing Regimens — 2.36; 4.16; 0.81; 1.76 mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Voriconazole low dose (Drug); Voriconazole high dose (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Manjunath Prakash Pai
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steady-State Cmax and Cmin of Two Voriconazole Dosing Regimens |
2.36; 4.16; 0.81; 1.76 | — |
| PRIMARY Geometric Mean Ratio of the AUC Between the High and Low Dose Voriconazole |
2 | — |
| SECONDARY The Area Under the Curve Over the Dosing Interval for All Participants While on the High Dose and Low Dose Interventions. |
14.6; 29.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01030653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.