Nutrition Disorders, Obesity, Overweight
Conditions
Keywords
Micafungin, Body Weight, Anti-Infective Agents, Signs and Symptoms, Mycoses, Therapeutic Uses, Antifungal Agents, Overnutrition, Pharmacologic Actions
Brief summary
The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.
Detailed description
This is a single center study. A total of 36 adult volunteers will be consented for the study. Volunteers will be admitted for an overnight stay. Half will be female and half male. Twelve volunteers will have a body mass index (BMI) less than 25 kg/m2, 12 will have a BMI 25-40 kg/m2, and 12 will have a BMI greater than 40 kg/m2. Volunteers will have height and weight measured after they have consented to participate. Exactly half the volunteers in each category will received a single dose of intravenous micafungin of 100 mg, while the other half will receive 300 mg as determined by a coin flip. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1, 4, 8, 12, 16, and 24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw, and the volunteer discharged from the study. Compensation will be provided to the participants for their time.
Interventions
DRUGMicafungin
100 mg IV infusion over 1 hour
Sponsors
Astellas Pharma US, Inc.
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects * 18 years or older * All racial and ethnic origins * English or Spanish speaking
Exclusion criteria
* Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of micafungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of micafungin, 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. * Creatinine Clearance \< 70 ml/min as estimated by the Cockcroft-Gault equation * History of allergies to echinocandins * Echinocandins are contraindicated for any reason * Volunteers unwilling to comply with study procedures. * Suspected or documented systemic fungal infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Clearance of Micafungin | 0-24 Hrs |
Countries
United States
Participant flow
Pre-assignment details
The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available
Participants by arm
| Arm | Count |
|---|---|
| Subjects Recieving 100 mg of Micafungin Micafungin: 100 mg IV infusion over 1 hour | 0 |
| Subjects Recieving 300 mg of Micafungin Micafungin: 300 mg IV infusion over 1 hour | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Serum Clearance of Micafungin
Time frame: 0-24 Hrs
Population: The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available