Study of Naldemedine Safety and Body Processing in Children Aged 2 to 18 Receiving Opioid Treatment

What this Trial Is About

Researchers are evaluating the pharmacokinetic profile of naldemedine and its metabolite nor-naldemedine after a single oral dose in children aged 2 to 18 years who are receiving or about to receive opioid treatment. The study focuses on pediatric participants experiencing or expected to develop opioid-induced constipation, aiming to understand how the drug behaves in their bodies. This is a Phase 12 open-label study designed to assess safety, tolerability, and drug levels in this population. Participants are divided into three age cohorts 12 to under 18 years, 6 to under 12 years, and 2 to under 6 years. Each participant receives a daily dose of naldemedine, ranging from 0.05 mg to 0.2 mg based on body weight, for 7 days. The drug is given as an oral tablet 0.2 mg dose only or oral suspension all doses. Cohort 3 enrollment occurs after safety and pharmacokinetics data from the first two cohorts are reviewed. During the study, participants will have blood samples collected at multiple time points on Day 1, Day 2, and Day 7 for Cohort 1 to measure drug concentration and related pharmacokinetic parameters. Researchers will also monitor for any treatment-emergent adverse events and assess the ability to swallow tablets and the palatability of the oral suspension. The total participation spans at least 7 days of dosing with monitoring of safety and drug behavior throughout this period.

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids