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Population Pharmacokinetic Analysis of Anidulafungin in Normal, Overweight and Obese Volunteers

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City:   Dallas
State:   Texas
Zip Code:   75390
Conditions:   Obesity - Mycoses
Purpose:   This study will find how weight affects the dosing of a drug called anidulafungin. Currently, the amount of anidulafungin a patient receives is the same regardless of the patient's weight.
Study Summary:  
Criteria:   Inclusion Criteria: - Male and female subjects, age > 18 years old, of all racial and ethnic origins. - Non-English-speaking Spanish speakers will be included in the study. - The investigators are recruiting six normal or underweight (BMI < 25 kg/m2), six overweight or obese (BMI 25-40 kg/m2), and six extremely obese (BMI > 40 kg/m2) 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. Exclusion Criteria: - Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of anidulafungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of anidulafungin, so that the pregnancy and postpartum state would be a confounding variable. - Abnormal liver function tests: transaminases > 3 times upper limit of normal, Alkaline phosphatase > 3 times upper limit of normal, total bilirubin > 3 times upper limit of normal. - History of allergies to echinocandins. - Echinocandins are contraindicated for any reason. - Volunteers unwilling to comply with study procedures. - Suspected or documented systemic fungal infection. - Concomitant use of rifamycins, tacrolimus, or cyclosporine. - Current participation or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance) (Unless waved by PI). - Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment (Unless waved by PI). - Creatinine Clearance < 70 ml/min as estimated by the Cockcroft-Gault equation.
NCT ID:   NCT01307930
Primary Contact:   Principal Investigator
Ronald Hall, PharmD, MSCS
Texas Tech UHSC

Backup Contact:   N/A
Location Contact:   Dallas, Texas 75390
United States



There is no listed contact information for this specific location.

Site Status: N/A

Data Source:   ClinicalTrials.gov
Date Processed:   April 22, 2014
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
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