Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

Texas Tech University Health Sciences Center

Status and phase: Completed; Phase 4

Conditions: Fungal Infection; Obesity

Treatments: Drug: Caspofungin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01062165

5UL1RR024982-02 (U.S. NIH Grant/Contract)

TTHSC-A09-3566

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

18 participants in 1 patient group

Capsofungin

Experimental group

Description:

Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.

Treatment:

Drug: Caspofungin