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NCT Number: NCT02099591

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

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.

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Key information

Conditions

Constipation, Signs and Symptoms, Digestive Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Opioid-Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Odense University Hospital, Odense, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naloxegol

Drug

Opioid Antagonist

Other names: Moventig

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Palatability of naloxegol liquid drug formulation

    Time frame: Day 1 and Day 2 after dose

  3. Ability of the patient to swallow the tablet

    Time frame: Day 1 and Day 2 after dose

  4. Clinical outcome measures by assessment of laxative use

    Time frame: From Day 1 until the End of treatment (26 week of study)

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Pharmaceutical Development Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2014
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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