View Clinical Trial (Medical Research Study)
Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
| 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 - Nutrition Disorders - Overweight |
| Purpose: |
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The purpose of this study is to assess the drug concentration of Micafungin amongst healthy
volunteers having different weight groups.
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| Study Summary: |
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This is a single center study. A total of 36 adult volunteers will be consented for the
study. Volunteers will be admitted for an overnight stay. Half will be female and half male.
Twelve volunteers will have a body mass index (BMI) less than 25 kg/m2, 12 will have a BMI
25-40 kg/m2, and 12 will have a BMI greater than 40 kg/m2. Volunteers will have height and
weight measured after they have consented to participate. Exactly half the volunteers in
each category will received a single dose of intravenous micafungin of 100 mg, while the
other half will receive 300 mg as determined by a coin flip. The volunteers will have blood
drawn via an intravenous catheter just prior to the dose, and then at 1, 4, 8, 12, 16, and
24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw,
and the volunteer discharged from the study. Compensation will be provided to the
participants for their time.
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| Criteria: |
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Inclusion Criteria:
- Male and female subjects
- 18 years or older
- All racial and ethnic origins
- English or Spanish speaking
Exclusion Criteria:
- Pregnant or nursing or unwilling to use a reliable contraception method during the
study. The effects of micafungin on pregnancy are unknown. In addition, the metabolic
changes that accompany pregnancy may alter the concentration-time profile of
micafungin, so that the pregnancy and post-partum state would be a confounding
variable.
- Abnormal liver function tests: transaminases>10 times upper limit of normal,
Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times
upper limit of normal.
- Creatinine Clearance < 70 ml/min as estimated by the Cockcroft-Gault equation
- History of allergies to echinocandins
- Echinocandins are contraindicated for any reason
- Volunteers unwilling to comply with study procedures.
- Suspected or documented systemic fungal infection.
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| NCT ID: |
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NCT01090141 |
| Primary Contact: |
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Principal Investigator
Tawanda Gumbo, MD
University of Texas Southwestern Medical Center at Dallas
Daniel Hernandez, BS
Phone: 214-648-3329
Email: daniel.hernandez@utsouthwestern.edu
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| Backup Contact: |
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Email: amit.gode@utsouthwestern.edu
Amit Gode, MPH
Phone: 214-648-0417
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| Location Contact: |
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Dallas, Texas 75390
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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