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RECRUITING
NCT05588323
PHASE1/PHASE2

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Sponsor: Shionogi

View on ClinicalTrials.gov

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

Interventions

DRUG

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