Trials / Recruiting
RecruitingNCT05588323
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
A Phase 1/2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment With Opioids
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Shionogi · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naldemedine | Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels) |
Timeline
- Start date
- 2023-01-04
- Primary completion
- 2026-06-15
- Completion
- 2026-06-15
- First posted
- 2022-10-20
- Last updated
- 2025-04-20
Locations
16 sites across 8 countries: Albania, Armenia, Belgium, Bosnia and Herzegovina, France, Italy, Japan, North Macedonia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05588323. Inclusion in this directory is not an endorsement.