Validation study for the comparison of ambrisentan concentrations
Research type
Research Study
Full title
An open-label, single dose study to compare ambrisentan (GSK1325760) concentrations determined using venous blood sampling and capillary micro sampling methods in healthy adult participants
IRAS ID
329563
Contact name
Ellen Jeremiah
Contact email
Sponsor organisation
GSK
Duration of Study in the UK
0 years, 3 months, 11 days
Research summary
Ambrisentan (GSK1325760) has been approved for use in children from the age of eight and upwards. The medication is used to treat high blood pressure in the blood vessels that supply the lungs. This condition is called pulmonary artery hypertension (PAH). There is a need to use this medication in even younger children from the age of four. To use it in this age group, a future study is needed. However, there is a limit to how much blood you can take in this age group. To decrease the amount of blood we take in children, it is necessary to use a device called Tasso-M20 that can take small amounts of blood. The present study is to test if the level of Ambrisentan in the blood when taken with the Tasso-M20 device, is similar to the level of Ambrisentan when taken from a vein. Participants will receive a single dose of 5mg of Ambrisentan. This is the lowest adult dose of Ambrisentan. Blood samples will then be taken at the same time with the Tasso device and from a vein to compare the levels of Ambrisentan from both methods. If the blood levels of Ambrisentan are similar with the device and from a vein, then the device can be used in the future study to enable less blood to be taken from children. The Tasso-M20 is a CE (Conformite Europeenne) marked and FDA (Food and Drug Administration) registered product. Ambrisentan is an approved medication, and the pharmacokinetic and safety profile has been established before. Therefore, this study is not considered a clinical trial of an investigational medicinal product. Approximately, 15 healthy male or female (of non-childbearing potential) participants between 18 and 65 years of age will take part. The study will last about 45 days.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0172
Date of REC Opinion
18 Jul 2023
REC opinion
Favourable Opinion