FDA-mandated in vitro platelet study

platelet aggregation, in vitro platelet study

The Client

This study was conducted for a mid-sized pharmaceutical client with a novel drug in development treating an orphan condition. The FDA mandated additional preclinical investigations due to concerns over cardiovascular risk seen with other drugs in the same class.

The Challenge

The first drug in this class had reports of ischemia. As a result of this the FDA required all drugs of similar types to be tested for platelet-activating effects to determine if this could be the cause of ischemia.

The Approach

Working closely with the client, and ensuring we met FDA requirements, at Java Clinical Research we designed an in vitro platelet function study to determine whether the novel drug had any measurable affect on platelets. In order to maximise the sensitivity of the study, we conducted assay development to optimise agonist conditions.

At Java Clinical Research, we subsequently tested responses in 20 healthy volunteers to an array of pretreatment conditions. Additional pharmacological tests were conducted in order to characterise the role of the drug target on platelets.

The Outcome

This preclinical study in human samples generated extensive data facilitating a comprehensive comparison with previous studies while providing additional conclusive results on the safety of the drug in question.

Java Clinical Research’s scientific team then prepared a detailed report for the FDA as well as a scientific publication.