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

The University of Texas System (UT)

Status and phase

Completed

Phase 4

Conditions

Overweight

Nutrition Disorders

Obesity

Treatments

Drug: Micafungin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01090141

BJ-07-003

Details and patient eligibility

About

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

Full description

This is a single center study. A total of 36 adult volunteers will be consented for the study. Volunteers will be admitted for an overnight stay. Half will be female and half male. Twelve volunteers will have a body mass index (BMI) less than 25 kg/m2, 12 will have a BMI 25-40 kg/m2, and 12 will have a BMI greater than 40 kg/m2. Volunteers will have height and weight measured after they have consented to participate. Exactly half the volunteers in each category will received a single dose of intravenous micafungin of 100 mg, while the other half will receive 300 mg as determined by a coin flip. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1, 4, 8, 12, 16, and 24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw, and the volunteer discharged from the study. Compensation will be provided to the participants for their time.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.