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Clinical Trials in Italy / NCT05588323
Recruiting Phase 1/2

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

NCT05588323 · tracked via the Priya Life Science Italy tracker
Sponsor
Shionogi
Phase
Phase 1/2
Started
2023-01-04
Last updated
2026-07-28

Condition(s) studied

Opioid-Induced Constipation (OIC)

Investigational drug(s) / intervention(s)

Naldemedine →

Naldemedine: Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels)

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 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. Weight * Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards. Exclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
University Center Mother Theresa , Hospital - Onco-hematology department Tirana Albania Not Yet Recruiting
Yeolyan Hematology. , and Oncology Center - Yerevan Armenia Recruiting
CHU Saint-Pierre Clinical Trials Unit Brussels Belgium Completed
Universitair Ziekenhuis Brussel (UZBrussel) - Department of Anesthesiology and Perioperative Medicine Brussels Belgium Completed
University Hospitals Leuven Pediatrisch hemato-oncology Leuven Belgium Completed
University Clinical Hospital , Mostar Mostar Bosnia and Herzegovina Recruiting
Chu de Caen Caen France Completed
Hôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH) Clamart France Completed
Hôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de Lille Lille France Completed
Hôpital Armand Trousseau Service Hématologie et Oncologie Pédiatrique Paris France Completed
Instituto Nazionale dei Tumori Milan Italy Completed
Citta della Salute e della Scienza di Torino Torino Italy Completed
Maternal and Child Health Institute IRCCS Burlo Garofolo, Pain and pediatric palliative care service Trieste Italy Completed
National Center for Child Health and Development Tokyo Japan Not Yet Recruiting
PHI University Clinic for Children's , Surgery Skopje North Macedonia Recruiting
University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy Skopje North Macedonia Recruiting

More Shionogi trials in Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05588323 on ClinicalTrials.gov ↗ ← All trials in Italy