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

June 14, 2024 updated by: Kyowa Kirin Pharmaceutical Development Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center, Oncology Institute
      • Petach Tikva, Israel, 49202
        • Schneider Children Medical Center
  • Norway
      • Bergen, Norway, 5021
        • Haukeland Universitetssykehus
      • Oslo, Norway, 0372
        • Oslo University Hospital - Rikshospitalet
      • Trondheim, Norway, 7006
        • St. Olavs Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Pediatric Oncology Unit Hospital Vall d'Hebron
      • Madrid, Spain, 28046
        • Hospital Infantil Universitario Nino Jesus
      • Madrid, Spain, 28050
        • Hospital Universitario Madrid Sanchinarro
      • Madrid, Spain, 28660
        • Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe
      • Murcia, Spain, 03191
        • Hospital Universitario Virgen de La Arrixaca
  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • The Leeds Teaching Hosptial NHS Trust
      • Liverpool, United Kingdom, L12 2AP
        • Alder Hey Children's Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham Children's Hospital
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Age group: > = 12y to < 18y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig
Experimental: Age group: > = 12y to < 18y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig
Experimental: Age group: > = 6y to < 12y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig
Experimental: Age group: > = 6y to < 12y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig
Experimental: Age group: > = 6mo to < 6y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig
Experimental: Age group: > = 6mo to < 6y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose
Palatability of naloxegol liquid drug formulation
Time Frame: Day 1 and Day 2 after dose
Day 1 and Day 2 after dose
Ability of the patient to swallow the tablet
Time Frame: Day 1 and Day 2 after dose
Day 1 and Day 2 after dose
Clinical outcome measures by assessment of laxative use
Time Frame: From Day 1 until the End of treatment (26 week of study)
From Day 1 until the End of treatment (26 week of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyowa Kirin Pharmaceutical Development Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Davies, Nottingham Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3820C00016
  • UTN: U1111-1154-5575 (Other Identifier: World Health Organization)
  • 2013-003935-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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