Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

Obesity Clinical Trial

Official title:

Population Pharmacokinetic Analysis of Caspofungin in Overweight and Obese Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062165
• Other study ID #: TTHSC-A09-3566
• Secondary ID: 5UL1RR024982-02
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2010
• Last updated: January 23, 2013
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2013
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center	National Center for Research Resources (NCRR), University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Clearance of Caspofungin		0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)	No