Trials / Completed
CompletedNCT02099591
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment With Opioids
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd · Industry
- Sex
- All
- Age
- 6 Months – 18 Years
- Healthy volunteers
- Not accepted
Summary
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naloxegol | Opioid Antagonist |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2021-04-01
- Completion
- 2021-04-01
- First posted
- 2014-03-31
- Last updated
- 2024-06-17
Locations
16 sites across 5 countries: Denmark, Israel, Norway, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02099591. Inclusion in this directory is not an endorsement.