Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations
|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.|
|ClinicalTrials.gov Identifier: NCT01307930|
Recruitment Status : Completed
First Posted : March 3, 2011
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Mycoses||Drug: Anidulafungin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Population Pharmacokinetic Analysis of Anidulafungin in Normal, Overweight and Obese Volunteers|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
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.
Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)
Other Name: Eraxis
- Serum Clearance of Anidulafungin [ Time Frame: 0-72 hours ]How quickly the body eliminates anidulafungin after a single dose
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
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Ronald Hall, PharmD, MSCS||Texas Tech UHSC|