A Single-dose Pilot Study to Evaluate the Pharmacokinetics of Pravastatin Given as an Oral Dose in Pediatric and Adolescent Subjects 12 Months to 16 Years of Age Receiving Continuous Cycling Peritoneal Dialysis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
Many children with end stage renal disease develop hyperlipidemia. HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are typical treatments for hyperlipidemia. However, we do not know how pravastatin is metabolized in patients on dialysis. This study is designed to provide preliminary pharmacokinetic data for pravastatin in pediatric patients on peritoneal dialysis.
详细描述
This is a single-dose pilot study to evaluate the pharmacokinetic profile of pravastatin in 7 pediatric and adolescent subjects ranging from 12 months to 16 years of age who are on dialysis. The study group will be comprised of healthy children receiving continuous cycling peritoneal dialysis (CCPD). Pravastatin dosing will be 10 mg in all subjects. Blood, urine, and dialysate samples will be obtained over a 24-hour period post-dose for measurement of pravastatin concentrations. Safety evaluations will include adverse events (AEs), physical examination, vital signs, and clinical laboratory evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 12 months to 18 years of age.
- •Patients with end stage renal disease who receive continuous cycling peritoneal dialysis.
- •signed informed consent
- •Physical exam demonstrates no abnormalities that would make this study medically hazardous to the subject.
排除标准
- •Any clinically significant unstable medical condition or chronic disease other than those associated with ESRD.
- •Any clinically significant illness within 10 days or receiving single-sdoe of study medication
- •History of rhabdomyolysis
- •Clinically significant liver disease or history of malabsorption or previous gastrointestinal surgery that could effect drug absorption or metabolism.
- •Clinical laboratory abnormalities: Aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine phosphokinase(CPK) > 2.5 times upper limit of normal; hemoglobin < 8.5 g.dL.
- •Known hypersensitivity to pravastatin
- •Unwilling to have blood samples drawn
- •Has taken a HMG-CoA reductase inhibitor in the last week -
研究组 & 干预措施
peritoneal dialysis (CCPD)
PK profile of pravastatin
干预措施: pravastatin (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 24 hours
次要结局
未报告次要终点