Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients
研究概览
简要总结
The primary objective of this study is to compare the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. The secondary objectives are to assess the pharmacodynamics (the study of the action or effects a drug has on the body) and to assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.
详细描述
This is an open-label (all people involved know the identity of the intervention), parallel-group, Phase 1 study in morbidly obese and non-obese men and women. A total of 25 patients (12 morbidly obese and 13 non-obese) patients will be enrolled in the study. Morbidly obese and nonobese patients are matched individually 1:1 by age (±10 years), sex, and renal function (as defined by creatinine levels in the urine). There are 4 phases in the clinical study: the pretreatment (screening/baseline) phase of up to 21 days; the 2-day open-label treatment phase when each patients receives a single 2-hour intravenous (directly into the vein) infusion of ceftobiprole 500 mg followed by multiple (up to 15) blood and urine samples drawn over the 24 hours following study drug administration; and the follow-up phase of approximately 1 week after the last blood sample when each patient will be monitored by telephone for development of new adverse events and assessment of ongoing adverse events. Each patient receives a single 2-hour infusion (directly into the vein) of ceftobiprole 500 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) =or > 40 kg/m2 or normal BMI between 18-30
- •Blood pressure 90-140 mm
- •Non-smoker
排除标准
- •History of medically significant illness
- •Uncontrolled hypertension
- •Uncontrolled high blood cholesterol and triglycerides
研究组 & 干预措施
Ceftobiprole (not morbidly obese subjects)
Ceftobiprole 500 mg single-dose over 2 hours.
干预措施: Ceftobiprole (Drug)
Ceftobiprole (morbidly obese subjects)
Ceftobiprole 500 mg single-dose over 2 hours.
干预措施: Ceftobiprole (Drug)
结局指标
主要结局
The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients
时间窗: up to 30 days (up to 21 days screening plus 2 days open-label treatment phase plus 1-week follow-up).
次要结局
- To assess the pharmacodynamics of ceftobiprole in morbidly obese patients and non-obese patients.(Up to 30 days (up to 21 days screening plus 2 days open label treatment phase plus 1-week follow-up))
- To assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.(Throughout the study from Day -1 through the post-study follow up)