# Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

> **NCT05588323** · PHASE1,PHASE2 · RECRUITING · sponsor: **Shionogi** · enrollment: 24 (estimated)

## Conditions studied

- Opioid-Induced Constipation (OIC)

## Interventions

- **DRUG:** Naldemedine

## Key facts

- **NCT ID:** NCT05588323
- **Lead sponsor:** Shionogi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-01-04
- **Primary completion:** 2026-06-15
- **Final completion:** 2026-06-15
- **Target enrollment:** 24 (ESTIMATED)
- **Last updated:** 2026-04-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05588323

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05588323, "Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT05588323. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*