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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Echinocandins; Micafungin

Criteria

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.