Population Pharmacokinetic Analysis of Anidulafungin in Normal, Overweight and Obese Volunteers
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| City: |
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Dallas |
| State: |
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Texas |
| Zip Code: |
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75390 |
| Conditions: |
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Obesity - Mycoses |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT01307930 |
| Primary Contact: |
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Principal Investigator
Ronald Hall, PharmD, MSCS
Texas Tech UHSC
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| Backup Contact: |
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N/A |
| Location Contact: |
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Dallas, Texas 75390
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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