Cognitive And Pharmacodynamic Testing During First-In-Human CNS Trials

This comprehensive review covers the timing and methodology for conducting cognitive and pharmacodynamic testing during first-in-human trials of CNS-active compounds. These tests are essential for characterizing the CNS profile of new drugs, providing critical safety data and proof-of-concept endpoints. From a safety perspective, identifying potential impairing effects, abuse potential, and risks of suicidality helps clarify regulatory requirements and possible exemptions. Early detection through these assessments can also predict target labeling and clinical study needs more accurately. Furthermore, cognitive and pharmacodynamic evaluations can serve as early proof-of-concept indicators. The choice of assessments depends on the drug's indication, mechanism of action, and study objectives, and may involve small cohorts of the intended patient population or healthy volunteers. The success of these studies hinges on selecting the most appropriate testing methods and target population, ensuring that results are interpretable and informative for pharmacodynamic test batteries, their applications, and limitations in first-in-human studies.

By watching this webinar, viewers will learn how to identify the necessary cognitive and pharmacodynamic tests for a novel CNS-active drug, determine the most relevant and valid populations for testing, and understand how cognitive and pharmacodynamic data can guide drug development and regulatory strategies.