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Completed

NCT Number: NCT01062165

Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

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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Key information

Conditions

Obesity Bacterial Infections and Mycoses Body Weight Fungal Infection Infections Mycoses Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caspofungin

Drug

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

Other names: Cancidas

Primary outcomes

  1. Total Clearance of Caspofungin

    Time frame: 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • University of Texas Southwestern Medical Center

Registry information

Official study title

Population Pharmacokinetic Analysis of Caspofungin in Overweight and Obese Volunteers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 4, 2010
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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