Clinical trial NCT02099591: Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Constipation, Signs and Symptoms, Digestive
Keywords: Constipation
Colonic Inertia
Dyschezia
Pharmacokinetics
Naloxegol
Paediatric
Opioids
Opioid induced constipation
OIC
Phase 1
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 61
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation
timeFrame: Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours
Secondary outcomes:
measure: To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1
timeFrame: Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose
measure: Palatability of naloxegol liquid drug formulation
timeFrame: Day 1 and Day 2 after dose
measure: Ability of the patient to swallow the tablet
timeFrame: Day 1 and Day 2 after dose
measure: Clinical outcome measures by assessment of laxative use
timeFrame: From Day 1 until the End of treatment (26 week of study)
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
city: Haifa
country: Israel
facility: Rambam Medical Center, Oncology Institute
city: Petach Tikva
country: Israel
facility: Schneider Children Medical Center
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Oslo
country: Norway
facility: Oslo University Hospital - Rikshospitalet
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Barcelona
country: Spain
facility: Pediatric Oncology Unit Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro
city: Madrid
country: Spain
facility: Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hosptial NHS Trust
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham Children's Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: Nottingham Children's Hospital
name: Patrick Davies
role: PRINCIPAL_INVESTIGATOR
References: