Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Serum Clearance of Micafungin
研究概览
简要总结
The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects
- •18 years or older
- •All racial and ethnic origins
- •English or Spanish speaking
排除标准
- •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.
研究组 & 干预措施
Subjects recieving 100 mg of Micafungin
干预措施: Micafungin (Drug)
Subjects recieving 300 mg of Micafungin
干预措施: Micafungin (Drug)
结局指标
主要结局
Serum Clearance of Micafungin
时间窗: 0-24 Hrs
次要结局
未报告次要终点