Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Texas Tech University Health Sciences Center
• Collaborators: National Center for Research Resources (NCRR); University of Texas Southwestern Medical Center
• Treatments: Caspofungin; Echinocandins

Criteria

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