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

November 2, 2020 updated by: University of Texas Southwestern Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subjects recieving 100 mg of Micafungin
Drug: Micafungin
100 mg IV infusion over 1 hour
Drug: Micafungin
300 mg IV infusion over 1 hour
Active Comparator: Subjects recieving 300 mg of Micafungin
Drug: Micafungin
100 mg IV infusion over 1 hour
Drug: Micafungin
300 mg IV infusion over 1 hour

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Principal Investigator: Tawanda Gumbo, MD, University of Texas, Southwestern Medical Center at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 18, 2010

First Posted (Estimate)

March 19, 2010

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJ-07-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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