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

Primary Purpose

Constipation, Signs and Symptoms, Digestive

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Naloxegol
Sponsored by
Kyowa Kirin Pharmaceutical Development Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation, Signs and Symptoms, Digestive focused on measuring Constipation, Colonic Inertia, Dyschezia, Pharmacokinetics, Naloxegol, Paediatric, Opioids, Opioid induced constipation, OIC, Phase 1

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University Hospital
  • Rambam Medical Center, Oncology Institute
  • Schneider Children Medical Center
  • Haukeland Universitetssykehus
  • Oslo University Hospital - Rikshospitalet
  • St. Olavs Hospital
  • Pediatric Oncology Unit Hospital Vall d'Hebron
  • Hospital Infantil Universitario Nino Jesus
  • Hospital Universitario Madrid Sanchinarro
  • Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe
  • Hospital Universitario Virgen de la Arrixaca
  • The Leeds Teaching Hosptial NHS Trust
  • Alder Hey Children's Hospital
  • Royal Marsden Hospital
  • Nottingham Children's Hospital
  • Oxford University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Age group: > = 12y to < 18y - Lower dose

Age group: > = 12y to < 18y - Higher dose

Age group: > = 6y to < 12y - Lower dose

Age group: > = 6y to < 12y - Higher dose

Age group: > = 6mo to < 6y - Lower dose

Age group: > = 6mo to < 6y - Higher dose

Arm Description

Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.

Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.

Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.

Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.

Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.

Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.

Outcomes

Primary Outcome Measures

To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation

Secondary Outcome Measures

To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1
Palatability of naloxegol liquid drug formulation
Ability of the patient to swallow the tablet
Clinical outcome measures by assessment of laxative use

Full Information

First Posted
February 13, 2014
Last Updated
August 30, 2022
Sponsor
Kyowa Kirin Pharmaceutical Development Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02099591
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Pharmaceutical Development Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Signs and Symptoms, Digestive
Keywords
Constipation, Colonic Inertia, Dyschezia, Pharmacokinetics, Naloxegol, Paediatric, Opioids, Opioid induced constipation, OIC, Phase 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Age group: > = 12y to < 18y - Lower dose
Arm Type
Experimental
Arm Description
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Arm Title
Age group: > = 12y to < 18y - Higher dose
Arm Type
Experimental
Arm Description
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Arm Title
Age group: > = 6y to < 12y - Lower dose
Arm Type
Experimental
Arm Description
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Arm Title
Age group: > = 6y to < 12y - Higher dose
Arm Type
Experimental
Arm Description
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Arm Title
Age group: > = 6mo to < 6y - Lower dose
Arm Type
Experimental
Arm Description
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Arm Title
Age group: > = 6mo to < 6y - Higher dose
Arm Type
Experimental
Arm Description
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Intervention Type
Drug
Intervention Name(s)
Naloxegol
Other Intervention Name(s)
Moventig
Intervention Description
Opioid Antagonist
Primary Outcome Measure Information:
Title
To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation
Time Frame
Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours
Secondary Outcome Measure Information:
Title
To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1
Time Frame
Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose
Title
Palatability of naloxegol liquid drug formulation
Time Frame
Day 1 and Day 2 after dose
Title
Ability of the patient to swallow the tablet
Time Frame
Day 1 and Day 2 after dose
Title
Clinical outcome measures by assessment of laxative use
Time Frame
From Day 1 until the End of treatment (26 week of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Davies
Organizational Affiliation
Nottingham Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Rambam Medical Center, Oncology Institute
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Schneider Children Medical Center
City
Petach Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Oslo University Hospital - Rikshospitalet
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Pediatric Oncology Unit Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Infantil Universitario Nino Jesus
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Madrid Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe
City
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
03191
Country
Spain
Facility Name
The Leeds Teaching Hosptial NHS Trust
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Alder Hey Children's Hospital
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Nottingham Children's Hospital
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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