Effect of Weight and/or Obesity on Caspofungin Drug Concentrations
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
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:
|
Outcome Measures
Primary Outcome Measures
- Total Clearance of Caspofungin [0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)]
Eligibility Criteria
Criteria
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.- TTHSC-A09-3566
- 5UL1RR024982-02
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
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
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 |
ronald.hall@ttuhsc.edu |
- TTHSC-A09-3566
- 5UL1RR024982-02