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Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Sponsor: Shionogi
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2023-01-04
Completion Date
2026-06-15
Last Updated
2025-04-20
Healthy Volunteers
No
Conditions
Interventions
Naldemedine
Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels)
Locations (16)
University Center Mother Theresa , Hospital - Onco-hematology department
Tirana, Albania
Yeolyan Hematology. , and Oncology Center -
Yerevan, Armenia
CHU Saint-Pierre Clinical Trials Unit
Brussels, Belgium
Universitair Ziekenhuis Brussel (UZBrussel) - Department of Anesthesiology and Perioperative Medicine
Brussels, Belgium
University Hospitals Leuven Pediatrisch hemato-oncology
Leuven, Belgium
University Clinical Hospital , Mostar
Mostar, Bosnia and Herzegovina
Chu de Caen
Caen, France
Hôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH)
Clamart, France
Hôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de Lille
Lille, France
Hôpital Armand Trousseau Service Hématologie et Oncologie Pédiatrique
Paris, France
Instituto Nazionale dei Tumori
Milan, Italy
Citta della Salute e della Scienza di Torino
Torino, Italy
Maternal and Child Health Institute IRCCS Burlo Garofolo, Pain and pediatric palliative care service
Trieste, Italy
National Center for Child Health and Development
Tokyo, Japan
PHI University Clinic for Children's , Surgery
Skopje, North Macedonia
University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy
Skopje, North Macedonia