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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects recieving 100 mg of Micafungin | Active Comparator |
| |
| Subjects recieving 300 mg of Micafungin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | 100 mg IV infusion over 1 hour |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Clearance of Micafungin | 0-24 Hrs |
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Inclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Tawanda Gumbo, MD | University of Texas, Southwestern Medical Center at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Recieving 100 mg of Micafungin | Micafungin: 100 mg IV infusion over 1 hour |
| FG001 | Subjects Recieving 300 mg of Micafungin | Micafungin: 300 mg IV infusion over 1 hour |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Recieving 100 mg of Micafungin | Micafungin: 100 mg IV infusion over 1 hour |
| BG001 | Subjects Recieving 300 mg of Micafungin | Micafungin: 300 mg IV infusion over 1 hour |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Clearance of Micafungin | 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 | Posted | 0-24 Hrs |
|
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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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Recieving 100 mg of Micafungin | Micafungin: 100 mg IV infusion over 1 hour |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tawanda Gumbo | Unknown | Unknown@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009748 | Nutrition Disorders |
| D050177 | Overweight |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D009181 | Mycoses |
| D044343 | Overnutrition |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Micafungin |
| Drug |
300 mg IV infusion over 1 hour |
|
| BG002 | Total | Total of all reporting groups |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Subjects Recieving 300 mg of Micafungin | Micafungin: 300 mg IV infusion over 1 hour | 0 | 0 | 0 | 0 | 0 | 0 |
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| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |