Clinical trial NCT01090141: Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
Official title: Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Nutrition Disorders
Overweight
Keywords: Micafungin
Body Weight
Anti-Infective Agents
Signs and Symptoms
Mycoses
Therapeutic Uses
Antifungal Agents
Overnutrition
Pharmacologic Actions
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2010-03-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Serum Clearance of Micafungin
timeFrame: 0-24 Hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Tawanda Gumbo, MD
role: PRINCIPAL_INVESTIGATOR
References: