Effect of Body Mass on Filgrastim Pharmacokinetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Systemic clearance of filgrastim in obese and non-obese patients
研究概览
简要总结
Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan.
Patients in this study will have blood draws once before they take Neupogen and 6 times after they take the Neuopen (for a total of 24 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched, non-obese patients will be enrolled into this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Receiving filgrastim at 5mcg/kg ± 10%
- •Admitted as an inpatient with an expected stay of at least 24 hours
- •Weight is > 190% of their ideal body weight (IBW) for "obese" patients or within 80 - 124% of IBW for matched control patients.
- •Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.
排除标准
- •Patients who have received filgrastim within 24 hours prior to enrollment
- •Patients who have received pegfilgrastim within 14 days prior to enrollment
- •Hypersensitivity reaction to filgrastim or any related product
- •Patients who have taken lithium within 7 days of enrollment
- •Serum Creatinine > 1.5 mg/dL
- •Patients who are pregnant or breastfeeding
- •Patients who are unable to understand and/or render informed consent
结局指标
主要结局
Systemic clearance of filgrastim in obese and non-obese patients
时间窗: 24 hours
次要结局
- Maximum concentration (Cmax) of filgrastim in obese and non-obese patients(24 hours)
- Alpha and beta half-life of filgrastim in obese and non-obese patients(24 hours)
- Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients(24 hours)
- Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients(24 hours)
研究者
Aaron Cumpston, PharmD, BCOP
Clinical Specialist - BMT
West Virginia University