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
3 other identifiers
interventional
61
5 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2014
Longer than P75 for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2014
CompletedFirst Posted
Study publicly available on registry
March 31, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedJune 17, 2024
June 1, 2024
6.4 years
February 13, 2014
June 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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)
Study Arms (6)
Age group: > = 12y to < 18y - Lower dose
EXPERIMENTALNaloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Age group: > = 12y to < 18y - Higher dose
EXPERIMENTALNaloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Age group: > = 6y to < 12y - Lower dose
EXPERIMENTALNaloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Age group: > = 6y to < 12y - Higher dose
EXPERIMENTALNaloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Age group: > = 6mo to < 6y - Lower dose
EXPERIMENTALNaloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Age group: > = 6mo to < 6y - Higher dose
EXPERIMENTALNaloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Interventions
Opioid Antagonist
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Odense University Hospital
Odense, 5000, Denmark
Rambam Medical Center, Oncology Institute
Haifa, 31096, Israel
Schneider Children Medical Center
Petah Tikva, 49202, Israel
Haukeland Universitetssykehus
Bergen, 5021, Norway
Oslo University Hospital - Rikshospitalet
Oslo, 0372, Norway
St. Olavs Hospital
Trondheim, 7006, Norway
Pediatric Oncology Unit Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Infantil Universitario Nino Jesus
Madrid, 28046, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe
Madrid, 28660, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, 03191, Spain
The Leeds Teaching Hosptial NHS Trust
Leeds, LS1 3EX, United Kingdom
Alder Hey Children's Hospital
Liverpool, L12 2AP, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Nottingham Children's Hospital
Nottingham, NG7 2UH, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Davies
Nottingham Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2014
First Posted
March 31, 2014
Study Start
November 1, 2014
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
June 17, 2024
Record last verified: 2024-06