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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.

Detailed 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.

Official Title
-----------------
Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers

Conditions
-----------------
Obesity, Nutrition Disorders, Overweight

Intervention / Treatment
-----------------
* Drug: Micafungin
* Drug: Micafungin


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subjects recieving 100 mg of Micafungin<br> | Drug: Micafungin<br>* 100 mg IV infusion over 1 hour<br>|
| Active Comparator: Subjects recieving 300 mg of Micafungin<br> | Drug: Micafungin<br>* 300 mg IV infusion over 1 hour<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Clearance of Micafungin |  | 0-24 Hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Micafungin, Body Weight, Anti-Infective Agents, Signs and Symptoms, Mycoses, Therapeutic Uses, Antifungal Agents, Overnutrition, Pharmacologic Actions