Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients - KODIAK16

Study identifier:D3820C00016

ClinicalTrials.gov identifier:NCT02099591

EudraCT identifier:2013-003935-32

CTIS identifier:N/A

Recruiting

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

Medical condition

Constipation, Signs and Symptoms, Digestive

Phase

Phase 1

Healthy volunteers

No

Study drug

Naloxegol

Sex

All

Estimated Enrollment

48

Study type

Interventional

Age

6 Months - 18 Years

Date

Study Start Date: 01 Nov 2014
Estimated Primary Completion Date: 01 Nov 2017
Estimated Study Completion Date: 01 Nov 2017

Study design

Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria