Pharmacokinetics of Ceftaroline in Normal and Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of ceftaroline following intravenous administration of a single 600 mg dose to healthy subjects
研究概览
简要总结
The purpose of this study is to characterize plasma and urinary concentrations of ceftaroline following intravenous administration of a single dose of ceftaroline 600 mg in healthy subjects who are normal weight, overweight, and obese.
详细描述
This study is planned to be a Phase I, open-label, single period, single-dose pharmacokinetic study conducted in 32 healthy adult male and female subjects. Adult subjects will be recruited and assigned to one of four groups based on their body mass index and total body weight. Subject will receive a single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion. Serial blood and urine samples will be collected over the next 12 hours to determine serum and urinary pharmacokinetics of ceftaroline. Safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests (serum chemistry and hematology), pregnancy testing (female subjects only), monitoring of adverse events, and recording of concomitant medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adult subjects
- •nonsmokers within the last 1 year
- •body mass index and total body weight within specific categories
排除标准
- •history of significant hypersensitivity reaction or intolerance to ceftaroline or beta-lactam agents or heparin
- •aspartate or alanine aminotransferase >3 times the upper limit of normal
- •estimated creatinine clearance <60 mL/minute and serum creatinine >1.5 mg/dL
- •female subjects who are pregnant or breast feeding
- •history of alcohol or substance abuse or dependence within the last 1 year
- •use of prescription or nonprescription drugs within last 7 to 14 days
- •participations in a clinical trials within last 30 days
- •donated blood (>500 mL) within the last 56 days
研究组 & 干预措施
Ceftaroline
Ceftaroline intravenous 600 mg single dose
干预措施: Ceftaroline (Drug)
结局指标
主要结局
Pharmacokinetics of ceftaroline following intravenous administration of a single 600 mg dose to healthy subjects
时间窗: 12 hours
Plasma maximum serum concentration of ceftaroline Area-under-the-concentration-time curve of ceftaroline: Time frame Predose (time zero \[0\]) to 12 hours Total body clearance of ceftaroline Apparent volume of distribution of ceftaroline Elimination rate constant of ceftaroline Elimination half-life of ceftaroline Renal clearance of ceftaroline: Time frame Predose (time zero \[0\]) to 12 hours Amount of ceftaroline excreted in the urine: Time frame Predose (time zero \[0\]) to 12 hours
次要结局
- To evaluate the safety and tolerability of intravenous ceftaroline(24 hours)
研究者
Keith A. Rodvold
Professor
University of Illinois at Chicago