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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


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
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