Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

Population Pharmacokinetic Analysis of Caspofungin in Overweight and Obese Volunteers

This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.

Inclusion Criteria:

• Male and female subjects, age 18 years of age or older, of all racial and ethnic origins. English and/or Spanish speaking volunteers are eligible to participate.

Exclusion Criteria:

• Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of caspofungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of caspofungin, 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.
• 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