Center of Excellence for Natural Product Drug Interaction Research (U54, Clinical Trial Required)

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for a Center of Excellence for Natural Product Drug Interaction Research to provide leadership in the study of natural product drug interactions. The ultimate goals of this program are to 1) clearly establish the clinical relevance of pharmacokinetic interactions from a select number of natural products, and 2) provide guidance and leadership to the broader research community on how best to research metabolism mediated drug interactions involving complex natural products. The Center will 1) identify, prioritize, source and characterize three to five natural products with potential to exhibit clinically significant interactions with commonly used medications; 2) perform all necessary preclinical work to characterize the interaction potential of the natural products including identifying the key mediators of any pharmacokinetic interaction as well as the mechanism(s) and magnitude of that interaction; 3) if warranted based on preclinical work, conduct rigorously designed clinical studies of these natural products to provide definitive data regarding the magnitude of any interaction in humans; 4) develop and maintain a repository for the data and methodology resources generated by this project as well as data generated by other researchers (especially the R21 grants funded through the companion RFA AT-20-001) regarding pharmacokinetic interactions involving natural products; and 5) provide ongoing guidance and leadership to the relevant research communities regarding how best to conduct research on pharmacokinetic natural product drug interactions; thereby facilitating better design of future research and ultimately better decisions regarding the concomitant use of medications and natural products.