Clinical Trial

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-06-15 -> 2028-06-15 2026-07-29
minor Completion pushed: 2026-06-15 -> 2028-06-15 2026-07-29
Trial Details
NCT Number NCT05588323
Lead Sponsor Shionogi
Conditions Opioid-Induced Constipation (OIC)
Enrollment 24 participants
Start Date 2023-01-04
Primary Completion 2028-06-15 (estimated)
Study Completion 2028-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-28