Nuvectis Pharma (NVCT) announced the completion of a clinical DDI study in healthy volunteers for NXP900, supporting NXP900’s potential as a combination partner with leading therapies. Drug-drug interaction studies help identify the potential for side effects, or in some cases, reduced therapeutic efficacy, that may be caused by interactions between different drugs. Key Study Objective: to determine whether NXP900 is an inducer of CYP3A, and if so, to classify its induction as weak, moderate or strong as per ICH M12 guidelines; study population: 14 healthy volunteers; key pharmacokinetics result: NXP900 increased the concentration of Midazolam, a known CYP3A sensitive substrate, by less than 2-fold, classifying it as a weak inhibitor of CYP3A. No serious or severe adverse events were reported in this study; diarrhea and non-infection related increases in white blood cell counts were the most common adverse events reported, all mild to moderate in intensity. These results support the combination strategy of NXP900 with EGFR/ALK Inhibitors in NSCLC and potentially additional combinations.
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