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Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

NCT05588323 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-29

No results posted yet for this 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.

Conditions

  • Opioid-Induced Constipation (OIC)

Interventions

DRUG

Naldemedine

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

Sponsors & Collaborators

  • Shionogi

    lead INDUSTRY

Principal Investigators

  • Shionogi Clinical Trials Administrator Clinical Support Help Line · Shionogi

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-04
Primary Completion
2026-06-15
Completion
2026-06-15
FDA Drug
Yes

Countries

  • Albania
  • Armenia
  • Belgium
  • Bosnia and Herzegovina
  • France
  • Italy
  • Japan
  • North Macedonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05588323 on ClinicalTrials.gov