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Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307930
First Posted: March 3, 2011
Last Update Posted: October 12, 2017
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.
Collaborators:
National Center for Research Resources (NCRR)
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Ron Hall, Texas Tech University Health Sciences Center
  Purpose
This study will find how weight affects the dosing of a drug called anidulafungin. Currently, the amount of anidulafungin a patient receives is the same regardless of the patient's weight. BMI groups were for enrollment purposes only and not used for ordinal data analysis.

Condition Intervention Phase
Obesity Mycoses Drug: Anidulafungin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Population Pharmacokinetic Analysis of Anidulafungin in Normal, Overweight and Obese Volunteers

Resource links provided by NLM:


Further study details as provided by Ron Hall, Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Serum clearance of anidulafungin [ Time Frame: 0-72 hours ]
    How quickly the body eliminates anidulafungin after a single dose


Enrollment: 18
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anidulafungin
Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Drug: Anidulafungin
Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)
Other Name: Eraxis

Detailed Description:

This study is designed to measure drug concentrations in the blood of volunteers administered a single intravenous dose of anidulafungin. The volunteers to be enrolled will not have either candidiasis or any other fungal infection. This is a single center study. Up to a total of 35 adult volunteers will be consented for the study at the Clinical and Translational Research Center (CTRC). Eighteen of these volunteers are needed to complete the study. The others will likely be screen failures, which is more likely in the BMI > 40 kg/m2 group. Volunteers will be admitted to the CTRC for an overnight stay. Half will be female and half male. Six volunteers will have a body mass index (BMI) less than 25 kg/m2, six will have a BMI 25-40 kg/m2, and six will have a BMI greater than 40 kg/m2.

** BMI groups will only be used for patient enrollment and not for data analysis. total body weight will be used as a continuous variable for data analysis. **

Volunteers will have height and weight measured after they have consented to participate. All volunteers in each category will receive a single dose of intravenous anidulafungin of 100 mg. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1.5, 8, 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. The volunteer will be asked to return to the CTRC outpatient center at 48 and 72 hours to have the final 2 blood draws conducted. Subjects who are excluded from study participation due to their laboratory results will be provided with a copy of their results and an explanation of the reason for ineligibility.

  Eligibility

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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, age > 18 years old, of all racial and ethnic origins.
  • Non-English-speaking Spanish speakers will be included in the study.
  • The investigators are recruiting six normal or underweight (BMI < 25 kg/m2), six overweight or obese (BMI 25-40 kg/m2), and six extremely obese (BMI > 40 kg/m2) for this study. This index is calculated using the volunteer's height and weight (Formula: weight (lb) / [height (in)]2 x 703). Half of each group will be male; the other half will be female.

Exclusion Criteria:

  • Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of anidulafungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of anidulafungin, so that the pregnancy and postpartum state would be a confounding variable.
  • Abnormal liver function tests: transaminases > 3 times upper limit of normal, Alkaline phosphatase > 3 times upper limit of normal, total bilirubin > 3 times upper limit of normal.
  • History of allergies to echinocandins.
  • Echinocandins are contraindicated for any reason.
  • Volunteers unwilling to comply with study procedures.
  • Suspected or documented systemic fungal infection.
  • Concomitant use of rifamycins, tacrolimus, or cyclosporine.
  • Current participation or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance) (Unless waved by PI).
  • Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment (Unless waved by PI).
  • Creatinine Clearance < 70 ml/min as estimated by the Cockcroft-Gault equation.
  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): NCT01307930


Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Texas Tech University Health Sciences Center
National Center for Research Resources (NCRR)
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Ronald Hall, PharmD, MSCS Texas Tech UHSC
  More Information

Responsible Party: Ron Hall, Associate Professor, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01307930     History of Changes
Other Study ID Numbers: A10-3616
5UL1RR024982-02 ( U.S. NIH Grant/Contract )
First Submitted: March 2, 2011
First Posted: March 3, 2011
Last Update Posted: October 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ron Hall, Texas Tech University Health Sciences Center:
Echinocandin
Obesity
Pharmacokinetics
Pharmacodynamics
Fungal infection

Additional relevant MeSH terms:
Obesity
Mycoses
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents