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Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01062165
First received: February 2, 2010
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Obesity
Fungal Infection
 Drug: Caspofungin
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Population Pharmacokinetic Analysis of Caspofungin in Overweight and Obese Volunteers

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Total Clearance of Caspofungin [ Time Frame: 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours) ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 2, 2010
Results First Received: December 13, 2012
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Mycoses
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013