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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01090141
First received: March 17, 2010
Last updated: March 23, 2010
Last verified: March 2010
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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

Primary Outcome Measures:
  • Serum clearance of Micafungin [ Time Frame: 0-24 Hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: November 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090141

Contacts
Contact: Daniel Hernandez, BS 214-648-3329 daniel.hernandez@utsouthwestern.edu
Contact: Amit Gode, MPH 214-648-0417 amit.gode@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
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

No publications provided

Responsible Party: Tawanda Gumbo, MD, Associate Professor, Internal Medicine, University of Texas Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT01090141     History of Changes
Other Study ID Numbers: BJ-07-003
Study First Received: March 17, 2010
Last Updated: March 23, 2010
Health Authority: United States: Institutional Review Board

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:
Nutrition Disorders
Obesity
Overweight
Overnutrition
Body Weight
Signs and Symptoms
 Micafungin
Anti-Infective Agents
Echinocandins
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents

ClinicalTrials.gov processed this record on May 21, 2013