Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Last updated: April 17, 2025
Sponsor: Shionogi
Overall Status: Active - Recruiting

Phase

1/2

Condition

Constipation

Treatment

Naldemedine

Clinical Study ID

NCT05588323
1907V921F
2019-003577-25
  • Ages 2-18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

Disease Characteristics

  • Participants with cancer or non-cancer pain who are receiving (or who are about toreceive) acute or chronic treatment with opioids.

  • Participants with either newly diagnosed constipation, a history of constipationtreated with laxatives, or are expected to develop constipation after opioidtreatment.

  • Able to remain in the clinic for blood sampling for at least 12 hours following thefirst 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 ageaccording to the World Health Organization Child Growth Standards.

Exclusion

Exclusion Criteria:

Medical Conditions

  • History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or anyrecent (within last 1 year) or planned GI tract surgery.

  • Signs or symptoms of GI obstruction or participants with recurrent obstruction whomay 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 informedconsent 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 renaldisease requiring hemodialysis, as determined by the investigator.

  • Progressive neurological disorders or potential disruption to the blood-brainbarrier (for example, primary brain malignancies, central nervous system metastases,active multiple sclerosis, etc.) considering the risk of opioid withdrawal orreduced 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.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Naldemedine
Phase: 1/2
Study Start date:
January 04, 2023
Estimated Completion Date:
June 15, 2026

Connect with a study center

  • University Center Mother Theresa , Hospital - Onco-hematology department

    Tirana,
    Albania

    Site Not Available

  • Yeolyan Hematology. , and Oncology Center -

    Yerevan,
    Armenia

    Active - 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

    Active - Recruiting

  • Chu de Caen

    Caen, 14033
    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

    Site Not Available

  • PHI University Clinic for Children's , Surgery

    Skopje,
    North Macedonia

    Active - Recruiting

  • University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy

    Skopje,
    North Macedonia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.