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