Pharmacokinetics of Telavancin 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
- Number (%) of adverse events of any severity regardless of relationship to study drug
研究概览
简要总结
The purpose of this study is to characterize plasma and urinary concentrations of telavancin following intravenous administration of a single dose of telavancin in healthy subjects who are normal weight, overweight, and obese.
详细描述
This study is a Phase I, open-label, single-dose pharmacokinetic study in healthy adult male and female subjects. Eligible subjects will be assigned to one of four groups based on their body mass index and total body weight. Subjects will receive a single dose of telavancin depending on subject's group as a 1-hour intravenous infusion. Serial blood and urine samples will be collected over 12 hours to determine serum and urinary pharmacokinetics of telavancin. Subjects will return for blood and urine sample collection at 24 and 48 hours. Safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests, monitoring of adverse events, and markers of kidney injury.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult subjects, 18 to 50 years
- •Nonsmokers within the last 1 year
- •Weight > 110 lbs
排除标准
- •History of significant hypersensitivity reaction or intolerance to telavancin
- •Aspartate or alanine aminotransferase > 1.5 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 (unless hormonal contraceptives) within 7 to 14 days prior to telavancin administration
- •Participation in a clinical trials within last 30 days
- •Donated blood (>500 mL) within the last 56 days
研究组 & 干预措施
Telavancin Administration
Single dose of telavancin administered as a 1-hour intravenous infusion
干预措施: Telavancin (Drug)
结局指标
主要结局
Number (%) of adverse events of any severity regardless of relationship to study drug
时间窗: 48 hours
Area-under-the-plasma concentration-time curve (AUC0-infinity)
时间窗: 48 hours
To estimate the telavancin pharmacokinetic parameter area-under-the-plasma concentration-time curve (AUC0-infinity) after a single dose of telavancin in healthy adult participants
Maximum plasma concentration (Cmax)
时间窗: 48 hours
To estimate the telavancin pharmacokinetic parameter maximum plasma concentration (Cmax) after a single dose for intravenously dosed telavancin to healthy adult participants
次要结局
未报告次要终点
研究者
Keith A. Rodvold
Professor
University of Illinois at Chicago