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

Primary Purpose

Obesity, Nutrition Disorders, Overweight

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Micafungin
Micafungin
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Micafungin, Body Weight, Anti-Infective Agents, Signs and Symptoms, Mycoses, Therapeutic Uses, Antifungal Agents, Overnutrition, Pharmacologic Actions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Subjects recieving 100 mg of Micafungin

Subjects recieving 300 mg of Micafungin

Arm Description

Outcomes

Primary Outcome Measures

Serum Clearance of Micafungin

Secondary Outcome Measures

Full Information

First Posted
March 17, 2010
Last Updated
November 2, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01090141
Brief Title
Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
Acronym
Micafungin
Official Title
Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Nutrition Disorders, Overweight
Keywords
Micafungin, Body Weight, Anti-Infective Agents, Signs and Symptoms, Mycoses, Therapeutic Uses, Antifungal Agents, Overnutrition, Pharmacologic Actions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects recieving 100 mg of Micafungin
Arm Type
Active Comparator
Arm Title
Subjects recieving 300 mg of Micafungin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Micafungin
Intervention Description
100 mg IV infusion over 1 hour
Intervention Type
Drug
Intervention Name(s)
Micafungin
Intervention Description
300 mg IV infusion over 1 hour
Primary Outcome Measure Information:
Title
Serum Clearance of Micafungin
Time Frame
0-24 Hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tawanda Gumbo, MD
Organizational Affiliation
University of Texas, Southwestern Medical Center at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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

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