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

Obesity Clinical Trial

— Micafungin  

Official title:

Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090141
• Other study ID #: BJ-07-003
• Status: Completed
• Phase: Phase 4
• Start date: November 2009
• Est. completion date: June 2010

Study information

• Verified date: November 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nutrition Disorders
• Obesity
• Overweight

Intervention

Drug:
• Micafungin
100 mg IV infusion over 1 hour
• Micafungin
300 mg IV infusion over 1 hour

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Clearance of Micafungin		0-24 Hrs