Effect of Weight and/or Obesity on Caspofungin Drug Concentrations
Information source: Texas Tech University Health Sciences Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Fungal Infection
Intervention: Caspofungin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Texas Tech University Health Sciences Center Official(s) and/or principal investigator(s):
Ronald Hall, PharmD, MSCS, Principal Investigator, Affiliation: Texas Tech University HSC
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.
Clinical Details
Official title: Population Pharmacokinetic Analysis of Caspofungin in Overweight and Obese Volunteers
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Total Clearance of Caspofungin
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States
Additional Information
Starting date: February 2010
Last updated: January 23, 2013
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