A Phase 1/2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment With Opioids

Shionogi17 个研究点分布在 8 个国家目标入组 24 人开始时间: 2023年1月4日最近更新: 2026年7月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 24
试验地点: 17
主要终点: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Naldemedine and Nor-naldemedine

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 2 Years 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Disease Characteristics
•Participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids.
•Participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment.
•Able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and are able to return for blood sampling at the 24-hour time point.
•Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards.

排除标准

•Medical Conditions
•History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or any recent (within last 1 year) or planned GI tract surgery.
•Signs or symptoms of GI obstruction or participants with recurrent obstruction who may be at increased risk of GI perforation.
•Inability to eat/swallow or have need of a nasogastric tube.
•No bowel movements reported for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1).
•History of more than 1 week of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 neutropenia or thrombocytopenia with clinical sequelae.
•Participants who need mechanical ventilation.
•Severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring hemodialysis, as determined by the investigator.
•Progressive neurological disorders or potential disruption to the blood-brain barrier (for example, primary brain malignancies, central nervous system metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia.
•Prior/Ongoing Medications
•Currently receiving the first cycle of chemotherapy.
•Previously received naldemedine.
•Other Exclusions
•- Positive pregnancy test for females of childbearing potential.
•Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

研究组 & 干预措施

Cohort 1: ≥ 12 to < 18 Years

Experimental

Participants will receive 0.05 milligrams (mg) to 0.2 mg naldemedine based on their body weight once daily for 7 days.

干预措施: Naldemedine (Drug)

Cohort 2: ≥ 6 to < 12 Years

Experimental

Participants will receive 0.05 mg to 0.2 mg naldemedine based on their body weight once daily for 7 days.

干预措施: Naldemedine (Drug)

Cohort 3: ≥ 2 to < 6 Years

Experimental

Participants will be enrolled in this cohort after the safety and PK data has been evaluated for cohorts 1 and 2.

Participants will receive 0.05 mg to 0.2 mg naldemedine based on their body weight once daily for 7 days.

干预措施: Naldemedine (Drug)

结局指标

主要结局

Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Naldemedine and Nor-naldemedine