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

Phase 1

Completed

• Conditions: Constipation, Signs and Symptoms, Digestive
• Interventions: Drug: Naloxegol

• Registration Number: NCT02099591
• Lead Sponsor: Kyowa Kirin Pharmaceutical Development Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-03-28
• Study First Posted: 2014-03-31
• Study Start: 2014-11
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Age group: > = 6mo to < 6y - Lower dose	Naloxegol	Naloxegol 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	Naloxegol	Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Age group: > = 12y to < 18y - Higher dose	Naloxegol	Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Age group: > = 6y to < 12y - Lower dose	Naloxegol	Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Age group: > = 12y to < 18y - Lower dose	Naloxegol	Naloxegol 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	Naloxegol	Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (16)

Royal Marsden Hospital; 🇬🇧 London, United Kingdom

Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe; 🇪🇸 Madrid, Spain

St. Olavs Hospital; 🇳🇴 Trondheim, Norway

Alder Hey Children's Hospital; 🇬🇧 Liverpool, United Kingdom

Hospital Universitario Madrid Sanchinarro; 🇪🇸 Madrid, Spain

Nottingham Children's Hospital; 🇬🇧 Nottingham, United Kingdom

Odense University Hospital; 🇩🇰 Odense, Denmark

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Rambam Medical Center, Oncology Institute; 🇮🇱 Haifa, Israel

Oslo University Hospital - Rikshospitalet; 🇳🇴 Oslo, Norway

Schneider Children Medical Center; 🇮🇱 Petach Tikva, Israel

Haukeland Universitetssykehus; 🇳🇴 Bergen, Norway

Hospital Infantil Universitario Nino Jesus; 🇪🇸 Madrid, Spain

Pediatric Oncology Unit Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

The Leeds Teaching Hosptial NHS Trust; 🇬🇧 Leeds, United Kingdom

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, United Kingdom