Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Texas Tech University Health Sciences Center
• Collaborators: National Center for Research Resources (NCRR); University of Texas Southwestern Medical Center
• Treatments: Anidulafungin; Echinocandins

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.