A Phase 1 Study to Evaluate Relative Bioavailability and Food Effect of an ALG-097558 Tablet Formulation and the Drug-Drug Interaction Potential of ALG-097558 and Its Metabolite ALG-097730 in Healthy Volunteers

Phase 1 randomized study sponsored by NIAID, enrolling 51 healthy volunteers to characterize the bioavailability, food effect, and drug-drug interaction profile of ALG-097558. Co-administration with itraconazole (a strong CYP3A4/P-gp inhibitor) increased ALG-097558 AUC ~3.5-fold and Cmax ~1.8-fold, while ALG-097558 (600 mg Q12H) produced only a modest ~1.2-fold rise in dabigatran AUC, consistent with weak-to-modest P-gp inhibition. A new conventional tablet was bioequivalent to the spray-dried dispersion formulation on total exposure (AUC GMR ~101%) but yielded a ~26% lower Cmax, and food modestly decreased AUC (~13%) while increasing Cmax (~24%).