Clinical trial

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

NCT02099591

Name

D3820C00016

Description

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.

Trial arms

Trial start

2014-11-01

Estimated PCD

2021-04-01

Trial end

2021-04-01

Status

Completed

Phase

Early phase I

Treatment

Naloxegol

Opioid Antagonist

Arms:

Age group: > = 12y to < 18y - Higher dose, Age group: > = 12y to < 18y - Lower dose, Age group: > = 6mo to < 6y - Higher dose, Age group: > = 6mo to < 6y - Lower dose, Age group: > = 6y to < 12y - Higher dose, Age group: > = 6y to < 12y - Lower dose

Other names:

Moventig

Size

Primary endpoint

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

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 61, 'type': 'ACTUAL'}}

Updated at

2024-06-17

1 organization

1 product

3 indications

Organization

Kyowa Kirin Pharmaceutical Development

Product

Indication

Indication

Indication