Drug-Drug Interaction Studies

By Karthi Natarajan, MPH, Medical Science Liaison

A sponsor developing an innovative treatment for cardiovascular disease engaged Altasciences to conduct two critical drug-drug interaction (DDI) studies. These studies were designed to evaluate how the sponsor’s new drug affects the pharmacokinetics and pharmacodynamics of two commonly prescribed cardiovascular treatments: clopidogrel, an antiplatelet agent, and warfarin, an anticoagulant. While initial data suggested that the sponsor’s drug was unlikely to interfere with the metabolism of either treatment, based on its metabolic profile, the studies were crucial to address the potential risk of excessive bleeding when these drugs were co-administered.

This collaboration highlights Altasciences’ broad expertise beyond standard DDI studies. Altasciences not only played a key role in designing the study protocols but also in recruiting appropriate participants and conducting the trials. Their approach was holistic, focusing not just on evaluating pharmacokinetic changes, but also on understanding the effects of co-administration on the antiplatelet and anticoagulant properties of clopidogrel and warfarin. Altasciences was particularly mindful of selecting the right patient population for the study and carefully timed the assessments to detect any subtle shifts in the pharmacodynamics of the drugs. This comprehensive, tailored approach ensured that the study addressed all potential safety concerns while delivering valuable insights for the sponsor.