Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers

2014-08-27 03:15:05 | BioPortfolio


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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment




Micafungin, Micafungin


University of Texas Southwestern Medical Center
United States




University of Texas Southwestern Medical Center

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:05-0400

Clinical Trials [729 Associated Clinical Trials listed on BioPortfolio]

Micafungin Pharmacokinetics in Obese Patients

Because micafungin is generally well tolerated and appears to have limited interaction with other drugs, it is a potential important agent in the treatment of invasive fungal infections. A...

Alternate Day Micafungin: A PK Study in Pediatric Patients

The purpose of this study is to examine the pharmacokinetics of micafungin when it is given on an every other day schedule. The study will determine if every other day micafungin will pro...

Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis

The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis. This study will also evaluate the p...

Pharmacokinetics of Micafungin in Newborns

The primary objective is to assess the pharmacokinetics of intravenously administered micafungin across a broad dose range of doses in infants younger than 120 days of age with suspected i...

Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins

The purpose of this pharmacokinetic and pharmacodynamic (PD) study is: To study the rate and duration of serum cidal activity of caspofungin and micafungin against Candida isolates from t...

PubMed Articles [2510 Associated PubMed Articles listed on BioPortfolio]

Micafungin use in a UK tertiary referral hospital.

We sought to describe the real-life usage of micafungin in our hospital.

Micafungin is a novel anti-viral agent of chikungunya virus through multiple mechanisms.

The chikungunya virus (CHIKV) is a mosquito-borne virus that belongs to the genus Alphavirus, family Togaviridae. It is the cause of chikungunya fever in humans, which presents a serious global threat...

Cutibacterium acnes protects Candida albicans from micafungin effect in biofilms.

The aim of this study was to investigate the ability of Candida albicans and Cutibacterium acnes to grow together as a polymicrobial biofilm in vitro and to examine the influence of C. acnes on C. alb...

Micafungin may be safely administered as outpatient parenteral antimicrobial therapy for chronic pulmonary aspergillosis.

Intravenous micafungin has been reported as a treatment alternative in patients with chronic pulmonary aspergillosis (CPA) where long-term oral triazole therapy is unfeasible.

Economic evaluation of micafungin versus liposomal amphotericin B (LAmB) for treating patients with candidaemia and invasive candidiasis (IC) in Turkey.

Micafungin was reported to be non-inferior to liposomal amphotericin B (LAmB) in treating patients with candidaemia and invasive candidiasis (IC). The current study aimed to evaluate the economic impa...

Medical and Biotech [MESH] Definitions

A condition of having excess fat in the abdomen. Abdominal obesity is typically defined as waist circumferences of 40 inches or more in men and 35 inches or more in women. Abdominal obesity raises the risk of developing disorders, such as diabetes, hypertension and METABOLIC SYNDROME X.

The condition of weighing two, three, or more times the ideal weight, so called because it is associated with many serious and life-threatening disorders. In the BODY MASS INDEX, morbid obesity is defined as having a BMI greater than 40.0 kg/m2.

A sub-PHENOTYPE of obese individuals who have a risk for CARDIOVASCULAR DISEASES between that of healthy individuals with normal weight and unhealthy individuals with obesity.

BODY MASS INDEX in children (ages 2-12) and in adolescents (ages 13-18) that is grossly above the recommended cut-off for a specific age and sex. For infants less than 2 years of age, obesity is determined based on standard weight-for-length percentile measures.

Agents that increase energy expenditure and weight loss by neural and chemical regulation. Beta-adrenergic agents and serotoninergic drugs have been experimentally used in patients with non-insulin dependent diabetes mellitus (NIDDM) to treat obesity.

More From BioPortfolio on "Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers"

Quick Search


Relevant Topics

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Searches Linking to this Trial