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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090141
First Posted: March 19, 2010
Last Update Posted: September 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  Purpose
The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.

Condition Intervention Phase
Obesity Nutrition Disorders Overweight Drug: Micafungin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Serum clearance of Micafungin [ Time Frame: 0-24 Hrs ]

Enrollment: 36
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subjects recieving 100 mg of Micafungin Drug: Micafungin
100 mg IV infusion over 1 hour
Active Comparator: Subjects recieving 300 mg of Micafungin Drug: Micafungin
300 mg IV infusion over 1 hour

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090141


Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Tawanda Gumbo, MD University of Texas, Southwestern Medical Center at Dallas
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01090141     History of Changes
Other Study ID Numbers: BJ-07-003
First Submitted: March 17, 2010
First Posted: March 19, 2010
Last Update Posted: September 15, 2014
Last Verified: March 2010

Keywords provided by University of Texas Southwestern Medical Center:
Micafungin
Body Weight
Anti-Infective Agents
Signs and Symptoms
Mycoses
Therapeutic Uses
Antifungal Agents
Overnutrition
Pharmacologic Actions

Additional relevant MeSH terms:
Overweight
Nutrition Disorders
Body Weight
Signs and Symptoms
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents