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PK Study of Ticagrelor in Children Aged Less Than 24 Months, With Sickle Cell Disease (HESTIA4) — HESTIA4  

Sickle Cell Disease Clinical Trial

Official title:
A Multi-centre, Phase I, Open-label, Single-dose Study to Investigate Pharmacokinetics (PK) of Ticagrelor in Infants and Toddlers, Aged 0 to Less Than 24 Months, With Sickle Cell Disease (HESTIA4)

Clinical Trial Summary

The purpose of this Phase I study is to investigate the pharmacokinetic properties of ticagrelor in pediatric patients from 0 to less than 24 months with sickle cell disease. Ticagrelor dose level adjustment will require a Protocol amendment and regulatory approval.

Clinical Trial Description

Study design This Phase I paediatric study (in patients aged 0 to <24 months) with ticagrelor is planned to be a multi-centre, open-label, single dose study. Primary Objective: To determine the PK properties of ticagrelor after a single oral dose Secondary Objectives: To determine the PK properties of the active metabolite (AR-C124910XX) after a single oral dose To assess the acceptability and the palatability of a single oral dose of ticagrelor Safety Objective: To assess safety and tolerability of a single oral dose of ticagrelor Duration of treatment At least 20 eligible patients will receive a single open label oral dose of ticagrelor on Day 1. Statistical methods A population PK analysis approach will be used to determine the PK parameters of ticagrelor and its metabolite AR-C124910XX in paediatric patients aged 0 to <24 months eg, CL/F (oral clearance) (only for ticagrelor) and AUC. The PK will also be described by presenting the observed plasma concentrations of Ticagrelor and its active metabolite for all individuals, as well as corresponding descriptive statistics. No statistical comparisons are planned for the primary or secondary objectives, which will be summarised descriptively ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03492931
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date March 28, 2018
Completion date May 7, 2019
View Details
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