This study was conducted for a small pharmaceutical company developing a set of compounds with a novel mechanism. The drug target is present in platelets and the client wanted to assess the effects of their drug on platelet function in an ex vivo setting.
The mechanism of this drug class meant that platelet function testing ex vivo required co-incubation of the drug with a co-factor. The client wanted Java Clinical Research to measure IC50 values for multiple compounds under various conditions.
Working closely with the client, we optimised assay conditions based to test the required parameters. We developed procedures to dissolve and dilute the drugs for use in platelet-rich plasma, and test the effects of the required co-factor to mimic conditions in vivo and generate relevant IC50 data.
We obtained healthy volunteer samples for testing, screening to ensure our donors were free from confounding drugs or other factors that might affect platelet function (including recent nicotine use, exercise, etc).
For each compound in the test series, we obtained platelet function data across a range of concentrations, yielding IC50 values from 10 healthy human donor samples under different circumstances. This data was analysed and compiled into a detailed report for our client, which formed part of an FDA submission package as they develop this compound series further.