PK & Safety of Naloxegol in Paediatric Patients Receiving Opioids
Research type
Research Study
Full title
A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages over 6 Months to under 18 Years Receiving Treatment with Opioids
IRAS ID
144974
Contact name
Patrick Davies
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2013-003935-32
Research summary
Research Summary
Paediatric patients who take a course of opioids are likely to develop opioid-induced constipation (OIC), which causes infrequent and often painful bowel movements. Furthermore, it is recognized that longer-term treatment of children with opioids often requires active bowel management to counteract OIC.
Currently there are no approved medicines for treatment of OIC in children. Therefore, there is a clear unmet medical need for an efficacious and well tolerated oral OIC therapy for children. Naloxegol is intended to treat this problem in the intestines without affecting opioids pain relief. There have been a number of clinical trials in adults showing naloxegol's efficacy and safety and naloxegol has been approved in US and EU for treatment of OIC in adults.
This study is being conducted to understand what doses of naloxegol should be used in children to treat constipation and to evaluate its side effects. Children from 6 months through 17 years of age will be enrolled into the study and will take naloxegol alongside their standard opioid treatment. They will have blood samples collected to assess the level of drug in their blood stream. The study will also observe how well young children like the taste of a liquid formulation, as well as the ability of older children to swallow the tablet form.Summary of Results
The study proceeded stepwise from the oldest to the youngest age group, with children given a dose of naloxegol that was calculated to be similar to 12.5 mg or 25 mg in adults. These calculations were based on age, weight and corresponded to doses that had already been tested in adults.
Blood levels of naloxegol were measured in 37 children and compared with levels previously seen in adults. The results showed that body weight did not affect blood levels and that dose adjustment is therefore not necessary. There were too few results to draw any conclusions on the taste of the liquid or acceptability of the tablets. Naloxegol was well tolerated and there were no new safety findings.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/0069
Date of REC Opinion
7 Mar 2014
REC opinion
Further Information Favourable Opinion