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Center for Global Research Data

Modeling and Simulation of ambrisentan pharmacokinetics in young children

Lead Investigator: Mary Ann Lukas, GlaxoSmithKline
Title of Proposal Research: Modeling and Simulation of ambrisentan pharmacokinetics in young children
Vivli Data Request: 7396
Funding Source: None
Potential Conflicts of Interest: Employee of GSK

Summary of the Proposed Research:

The data being requested will be incorporated into a modelling and simulation analysis of ambrisentan in the paediatric population (aged 4 to less than 8 years). This is being done for inclusion in GSK’s regulatory submission to EMA, as development in this age group is a requirement; these data provide important support for GSK’s position on development approach. Given this purpose, there is no specific mitigation planned or in our view needed for the relationship stated.
The detailed PK data requested will allow a comparison between the observed PK data in the 4-<8years and the simulated PK profiles in the 4- <8year group using the integrated population PK model in adult and children 8 to <18 years derived by GlaxoSmithKline. This work is being done to enhance the design of the exposure extrapolation strategy to the 4 to less than 8 year old population and will potentially be submitted in regulatory submission to EMA as supportive data

Requested Studies:

Safety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric Patients
Data Contributor: Duke University School of Medicine/Duke University Hospital
Study ID: NCT02080637
Sponsor ID: Pro00050118