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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

Page last updated: August 20, 2015

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