Clinical Trials in Japan / NCT05588323
Recruiting
Phase 1/2
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
NCT05588323 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Opioid-Induced Constipation (OIC)
Investigational drug(s) / intervention(s)
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
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)
- Maximum Plasma Concentration (Cmax) of Naldemedine and Nor-naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
- Time to Achieve Maximum Plasma Concentration (Tmax) of Naldemedine and Nor-naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
- Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Naldemedine and Nor-naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
- AUC Extrapolated From Time Zero to Infinity (AUC0-inf) of Naldemedine and Nor-naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
- Terminal Elimination Rate Constant (λz) of Naldemedine and Nor-naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
- Terminal Elimination Half-life (t1/2,z) of Naldemedine and Nor-naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
- Apparent Total Clearance (CL/F) of Naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
- Mean Residence Time (MRT) of Naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
- Apparent Volume of Distribution in the Terminal Phase (Vz/F) of Naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
- Metabolic Ratio of Cmax of Nor-naldemedine to Cmax of Naldemedine (MRM/U, Cmax) for Nor-naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
- Metabolic Ratio of AUC of Nor-naldemedine to AUC of Naldemedine (MRM/U, AUC) for Nor-naldemedine — Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Japan
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 Japan