Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers

Completed · Phase 4

Conditions studied: Obesity, Nutrition Disorders, Overweight

In brief

The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.

Key facts

Study ID

NCT01090141

Run by

University of Texas Southwestern Medical Center

People needed

36

Starts

2009-11-01

Expected to finish

2010-06-01

Last updated by the study team

2020-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects
• 18 years or older
• All racial and ethnic origins
• English or Spanish speaking

You may not qualify if…

• 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.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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