Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Recruiting now · Phase 1/Phase 2

Conditions studied: Opioid-Induced Constipation (OIC)

In brief

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.

Key facts

Study ID

NCT05588323

Run by

Shionogi

People needed

24

Starts

2023-01-04

Expected to finish

2028-06-15

Last updated by the study team

2026-07-28

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yeolyan Hematology. , and Oncology Center - — Yerevan, Armenia (enrolling)
• University Clinical Hospital , Mostar — Mostar, Bosnia and Herzegovina (enrolling)
• PHI University Clinic for Children's , Surgery — Skopje, North Macedonia (enrolling)
• University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy — Skopje, North Macedonia (enrolling)
• Chu de Caen — Caen, France
• Hôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH) — Clamart, France
• University Center Mother Theresa , Hospital - Onco-hematology department — Tirana, Albania
• 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
• Hôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de Lille — Lille, France
• 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

Full record on ClinicalTrials.gov

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