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Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

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ClinicalTrials.gov Identifier: NCT01062165
Recruitment Status : Completed
First Posted : February 4, 2010
Results First Posted : January 21, 2013
Last Update Posted : February 10, 2017
Sponsor:
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

Brief Summary:
This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.

Condition or disease Intervention/treatment Phase
Obesity Fungal Infection Drug: Caspofungin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Population Pharmacokinetic Analysis of Caspofungin in Overweight and Obese Volunteers
Study Start Date : February 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Capsofungin
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: Caspofungin
Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
Other Name: Cancidas




Primary Outcome Measures :
  1. Total Clearance of Caspofungin [ Time Frame: 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects, age 18 years of age or older, of all racial and ethnic origins. English and/or Spanish speaking volunteers are eligible to participate.

Exclusion Criteria:

  • Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of caspofungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of caspofungin, 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.
  • 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

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): NCT01062165


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 University HSC

Publications of Results:
Responsible Party: Ron Hall, Associate Professor, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01062165     History of Changes
Other Study ID Numbers: TTHSC-A09-3566
5UL1RR024982-02 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2010    Key Record Dates
Results First Posted: January 21, 2013
Last Update Posted: February 10, 2017
Last Verified: December 2016

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
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents