A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment With Opioids
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 16
- 主要终点
- To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation
研究概览
简要总结
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Age group: > = 12y to < 18y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
干预措施: Naloxegol (Drug)
Age group: > = 12y to < 18y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
干预措施: Naloxegol (Drug)
Age group: > = 6y to < 12y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
干预措施: Naloxegol (Drug)
Age group: > = 6y to < 12y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
干预措施: Naloxegol (Drug)
Age group: > = 6mo to < 6y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
干预措施: Naloxegol (Drug)
Age group: > = 6mo to < 6y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
干预措施: Naloxegol (Drug)
结局指标
主要结局
To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation
时间窗: Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours
次要结局
- To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1(Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose)
- Palatability of naloxegol liquid drug formulation(Day 1 and Day 2 after dose)
- Ability of the patient to swallow the tablet(Day 1 and Day 2 after dose)
- Clinical outcome measures by assessment of laxative use(From Day 1 until the End of treatment (26 week of study))