Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

Sponsor
Texas Tech University Health Sciences Center (Other)
Overall Status
Completed
CT.gov ID
NCT01062165
Collaborator
National Center for Research Resources (NCRR) (NIH), University of Texas Southwestern Medical Center (Other)
18
1
1
10
1.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Population Pharmacokinetic Analysis of Caspofungin in Overweight and Obese Volunteers
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

    Primary Outcome Measures

    1. Total Clearance of Caspofungin [0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas Southwestern Medical Center Dallas Texas United States 75390

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Ronald Hall, PharmD, MSCS, Texas Tech University HSC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ron Hall, Associate Professor, Texas Tech University Health Sciences Center
    ClinicalTrials.gov Identifier:
    NCT01062165
    Other Study ID Numbers:
    • TTHSC-A09-3566
    • 5UL1RR024982-02
    First Posted:
    Feb 4, 2010
    Last Update Posted:
    Feb 10, 2017
    Last Verified:
    Dec 1, 2016
    Keywords provided by Ron Hall, Associate Professor, Texas Tech University Health Sciences Center
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Volunteers recruited with fliers at medical center.
    Pre-assignment Detail
    Arm/Group Title Capsofungin
    Arm/Group Description 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. Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
    Period Title: Overall Study
    STARTED 18
    COMPLETED 18
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Capsofungin
    Arm/Group Description 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. Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
    Overall Participants 18
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    17
    94.4%
    >=65 years
    1
    5.6%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    41.1
    (13.2)
    Gender (Count of Participants)
    Female
    9
    50%
    Male
    9
    50%
    Region of Enrollment (participants) [Number]
    United States
    18
    100%

    Outcome Measures

    1. Primary Outcome
    Title Total Clearance of Caspofungin
    Description
    Time Frame 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Capsofungin
    Arm/Group Description 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. Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
    Measure Participants 18
    Mean (Standard Deviation) [L/hr]
    0.508
    (0.223)

    Adverse Events

    Time Frame 72 hours
    Adverse Event Reporting Description
    Arm/Group Title Capsofungin
    Arm/Group Description 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. Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
    All Cause Mortality
    Capsofungin
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Capsofungin
    Affected / at Risk (%) # Events
    Total 0/18 (0%)
    Other (Not Including Serious) Adverse Events
    Capsofungin
    Affected / at Risk (%) # Events
    Total 2/18 (11.1%)
    General disorders
    Headache 1/18 (5.6%) 1
    Hot flashes and sweating 1/18 (5.6%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Ronald Hall
    Organization Texas Tech UHSC
    Phone 214-654-9404
    Email ronald.hall@ttuhsc.edu
    Responsible Party:
    Ron Hall, Associate Professor, Texas Tech University Health Sciences Center
    ClinicalTrials.gov Identifier:
    NCT01062165
    Other Study ID Numbers:
    • TTHSC-A09-3566
    • 5UL1RR024982-02
    First Posted:
    Feb 4, 2010
    Last Update Posted:
    Feb 10, 2017
    Last Verified:
    Dec 1, 2016