LENA Pilot Investigation v1.0
Research type
Research Study
Full title
LENA Test on sampling of drug concentrations and humoral parameters and its corresponding logistics (Pilot investigation)
IRAS ID
198790
Contact name
Michael Burch
Contact email
Sponsor organisation
Ethicare GmbH
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
This Investigation is part of the FP7 funded, international LENA Research project (Labeling of Enalapril from Neonates up to Adolescents) aiming to provide a basis for a future PUMA (Paediatric Use Marketing Authorisation) for enalapril in an age-appropriate solid oral formulation.
In the course of these paediatric clinical trials, pharmacokinetic and pharmacodynamic data for enalapril are gathered, as well as safety data in the paediatric population.
However, the accuracy of pre-analytical sample preparation is crucial to reach the main objective of the paediatric clinical trials. Therefore in this pilot study blood will be taken from healthy volunteers with the aim of evaluating stability of the blood sample in transit to the processing lab.
This is a key element in determining the quality and reliability of the data generated during the project.
This training concept for study staff has been developed to determine its effectiveness in the scope of this intervention.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0124
Date of REC Opinion
29 Feb 2016
REC opinion
Favourable Opinion