Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Fungal Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Caspofungin

Intervention Type DRUG

Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)

Interventions

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Caspofungin

Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)

Intervention Type DRUG

Other Intervention Names

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Cancidas

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes