Back to resultsEffect of Weight and/or Obesity on Anidulafungin Drug Concentrations
Primary Purpose
Obesity, Mycoses
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Anidulafungin
Sponsored by
About this trial
This is an interventional other trial for Obesity focused on measuring Echinocandin, Obesity, Pharmacokinetics, Pharmacodynamics, Fungal infection
Eligibility 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.
Sites / Locations
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anidulafungin
Arm Description
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.
Outcomes
Primary Outcome Measures
Serum Clearance of Anidulafungin
How quickly the body eliminates anidulafungin after a single dose
Secondary Outcome Measures
Full Information
NCT ID
NCT01307930
First Posted
March 2, 2011
Last Updated
January 8, 2019
Sponsor
Texas Tech University Health Sciences Center
Collaborators
National Center for Research Resources (NCRR), University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01307930
Brief Title
Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations
Official Title
Population Pharmacokinetic Analysis of Anidulafungin in Normal, Overweight and Obese Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center
Collaborators
National Center for Research Resources (NCRR), University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Mycoses
Keywords
Echinocandin, Obesity, Pharmacokinetics, Pharmacodynamics, Fungal infection
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anidulafungin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Anidulafungin
Other Intervention Name(s)
Eraxis
Intervention Description
Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)
Primary Outcome Measure Information:
Title
Serum Clearance of Anidulafungin
Description
How quickly the body eliminates anidulafungin after a single dose
Time Frame
0-72 hours
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, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Hall, PharmD, MSCS
Organizational Affiliation
Texas Tech UHSC
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
Plan to Share IPD
No
Learn more about this trial
Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations
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