The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).
研究概览
简要总结
Multicenter, comparative single-dose pharmacokinetic (PK) study
详细描述
Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (GERD) following administration of an oral dose of pantoprazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is between 6 and 17 (inclusive) years of age at the time of consent
- •BMI ≥95th percentile
- •Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:
- •clinical symptoms consistent with GERD as determined by the investigator
- •a diagnosis of erosive esophagitis by endoscopy
- •esophageal biopsy with histopathology consistent with reflux esophagitis
- •abnormal pH-metry consistent with reflux esophagitis
- •other test result consistent with GERD
- •Written informed consent from the parent or legally authorized representative/guardian and participant assent per local IRB recommendation of age-appropriate consent and assent requirements
排除标准
- •Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
- •Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate, valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within seven days prior to dose of study drug
- •Consumption of food after midnight on the day of the baseline visit
- •Symptomatic asthma
- •Type I diabetes
- •History of adverse reaction to PPI
- •Impaired hepatic activity as defined as any of the following: AST ≥150 IU/L, ALT ≥150 IU/L, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 IU/L
- •Serum creatinine ≥2.0 mg/dL
- •For females of childbearing potential, a positive pregnancy test result
- •Known infection with hepatitis B, C, or HIV
- •Any other condition that, in the opinion of the principal investigator, makes participation unadvised or unsafe.
研究组 & 干预措施
Pantoprazole
干预措施: Pantoprazole (Drug)
结局指标
主要结局
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).
时间窗: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Cmax.
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).
时间窗: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Tmax.
PK Sampling
时间窗: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing
Total number of fresh plasma samples (all participants)
Drug Concentration in Plasma Samples
时间窗: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing
Concentration of panto in plasma and concentration of panto sulfone in plasma
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).
时间窗: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC LBW.
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).
时间窗: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report CL/F TBW.
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).
时间窗: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F LBW.
次要结局
- The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype(0, 1, 2, 3, 4, 6, 8, 12 hours post-dose)
研究者
Phillip Brian Smith
Principal Investigator
Duke University