Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations

Completed · Phase 4

Conditions studied: Obesity, Mycoses

In brief

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. BMI groups were for enrollment purposes only and not used for ordinal data analysis.

Key facts

Study ID

NCT01307930

Run by

Texas Tech University Health Sciences Center

People needed

20

Starts

2011-01-01

Expected to finish

2012-11-01

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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