Phase 4
Completed N=36
Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
Obesity · Nutrition Disorders · Overweight
Source: ClinicalTrials.gov NCT01090141 ↗
Enrolled (actual)
36
Serious AEs
—
Results posted
Nov 2020
Primary outcomePrimary: Serum Clearance of Micafungin
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Clearance of Micafungin |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01090141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.