drugset / Trial / NCT05588323
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Non-randomizedParallel-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2023-01-04
- Primary completion
- 2026-06-15
- Completion
- 2026-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naldemedine | Other / unclassified | 0.05 mg | Oral |
| Subject | Naldemedine | Other / unclassified | 0.2 mg | Oral |