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Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations

Information source: Texas Tech University Health Sciences Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity; Mycoses

Intervention: Anidulafungin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Texas Tech University Health Sciences Center

Official(s) and/or principal investigator(s):
Ronald Hall, PharmD, MSCS, Principal Investigator, Affiliation: Texas Tech UHSC


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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Serum clearance of anidulafungin


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States
Additional Information

Starting date: January 2011
Last updated: June 9, 2014

Page last updated: August 20, 2015

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