MedTrace Logo

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

NCT02099591 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-06-17

No results posted yet for this study

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.

Conditions

  • Constipation, Signs and Symptoms, Digestive

Interventions

DRUG

Naloxegol

Opioid Antagonist

Sponsors & Collaborators

  • Kyowa Kirin Pharmaceutical Development Ltd

    lead INDUSTRY

Principal Investigators

  • Patrick Davies · Nottingham Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Denmark
  • Israel
  • Norway
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099591 on ClinicalTrials.gov