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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02099591

Enrollment

Registered

2014-03-31

Start date

2014-11-30

Completion date

2021-04-30

Last updated

2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, Signs and Symptoms, Digestive

Keywords

Constipation, Colonic Inertia, Dyschezia, Pharmacokinetics, Naloxegol, Paediatric, Opioids, Opioid induced constipation, OIC, Phase 1

Brief 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.

Interventions

DRUGNaloxegol

Opioid Antagonist

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Years

Healthy volunteers

Inclusion criteria

Main inclusion criteria, patient with: * malignant or non-malignant pain who are receiving or (are about to receive) acute or chronic treatment with opioids * newly diagnosed constatipation, with history of constipation treated with laxatives or expected to develop constipation after opioid treatment * ability to be present in the clinic for at least 10 hours following the first study drug for blood sampling and to return at 24 hours for blood sampling. Main

Exclusion criteria

* Current acute or chronic use of methadone * History of an neoplasm or an ongoing gastrointestinal-related issue * Signs or symptoms of gastrointestinal obstruction * History of prolonged neutropenia or thrombocytopenia with clinical sequelae. * Patients currently receiving the first cycle of chemotherapy

Design outcomes

Primary

Measure	Time frame
To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation	Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours

Secondary

Measure	Time frame
To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1	Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose
Palatability of naloxegol liquid drug formulation	Day 1 and Day 2 after dose
Ability of the patient to swallow the tablet	Day 1 and Day 2 after dose
Clinical outcome measures by assessment of laxative use	From Day 1 until the End of treatment (26 week of study)

Countries

Denmark, Israel, Norway, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026