Population pharmacokinetic analysis of anidulafungin in normal, overweight and obese volunteers

Summary

This study is designed to measure drug concentrations in the blood of volunteers administered a single intravenous dose of anidulafungin. The volunteers to be enrolled will not have either candidiasis or any other fungal infection. This is a single center study. Up to a total of 35 adult volunteers will be consented for the study at the Clinical and Translational Research Center (CTRC). Eighteen of these volunteers are needed to complete the study. The others will likely be screen failures, which is more likely in the BMI >= 40 kg/m2 group. Volunteers will be admitted to the CTRC for an overnight stay. Half will be female and half male. Six volunteers will have a body mass index (BMI) less than 25 kg/m2, six will have a BMI 25-40 kg/m2, and six will have a BMI greater than 40 kg/m2. Volunteers will have height and weight measured after they have consented to participate. All volunteers in each category will receive a single dose of intravenous anidulafungin of 100 mg. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1.5, 8, 16, and 24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw, and the volunteer discharged from the study. The volunteer will be asked to return to the CTRC outpatient center at 48 and 72 hours to have the final 2 blood draws conducted.

Participant Eligibility

(1) Male and female subjects, age >18 years, of all racial and ethnic origins.
(2) Non-English speaking Spanish speakers will be included in the study.
(3) We are recruiting six normal or underweight (BMI <25 kg/m^2), six overweight or obese (BMI 25-40 kg/m^2), and six extremely obese (BMI > 40 kg/m^2) for this study. This index is calculated using the volunteer’s height and weight (Formula: weight (lb) / [height (in)]^2 x 703). Half of each group will be male; the other half will be female.