Fungal Infection, Obesity
Conditions
Keywords
Echinocandin, Obesity, Pharmacokinetics, Pharmacodynamics, Fungal infection
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.
Interventions
DRUGCaspofungin
Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
Sponsors
National Center for Research Resources (NCRR)
University of Texas Southwestern Medical Center
Texas Tech University Health Sciences Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Clearance of Caspofungin | 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours) |
Countries
United States
Participant flow
Recruitment details
Volunteers recruited with fliers at medical center.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug) | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Capsofungin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 41.1 years STANDARD_DEVIATION 13.2 |
| Gender Female | 9 Participants |
| Gender Male | 9 Participants |
| Region of Enrollment United States | 18 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Total Clearance of Caspofungin
Time frame: 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Capsofungin | Total Clearance of Caspofungin | 0.508 L/hr | Standard Deviation 0.223 |