NCT01062165已完成4 期
Population Pharmacokinetic Analysis of Caspofungin in Overweight and Obese Volunteers
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Total Clearance of Caspofungin
研究概览
简要总结
This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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, age 18 years of age or older, of all racial and ethnic origins. English and/or Spanish speaking volunteers are eligible to participate.
排除标准
- •Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of caspofungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of caspofungin, 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.
- •History of allergies to echinocandins.
- •Echinocandins are contraindicated for any reason.
- •Volunteers unwilling to comply with study procedures.
- •Suspected or documented systemic fungal infection.
- •Concomitant use of rifamycins, tacrolimus, or cyclosporine
研究组 & 干预措施
Capsofungin
Experimental
Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
干预措施: Caspofungin (Drug)
结局指标
主要结局
Total Clearance of Caspofungin
时间窗: 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)
次要结局
未报告次要终点
研究者
Ron Hall
Associate Professor
Texas Tech University Health Sciences Center
研究点 (1)
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