CompletedPhase 1

Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

Denmark, Israel, Norway61 participantsStarted 2014-11

Plain-language 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.

Who can participate

Age range6 Months – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT02099591

SponsorKyowa Kirin Pharmaceutical Development Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04

View on ClinicalTrials.gov More Constipation, Signs and Symptoms, Digestive trials