APTORUM GROUP LIMITED Aptorum Group Limited announced the finalized data from the Phase 1 clinical trial of SACT-1, a repurposed small molecule drug targeting Neuroblastoma and potentially other cancer types. Following the announcement of the Phase 1 clinical trial of SACT-1 in January 2022, Aptorum announced further data updates from the trial conducted by an independent clinical contract research organization. The Phase 1 clinical trial of SACT-1 was an open-label, randomized, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study of SACT-1 (oral suspension) in healthy adult volunteers.
The primary objective of this study was to assess the relative bioavailability of 150 mg of SACT-1 (oral suspension) under fasted and fed conditions. The secondary objectives were to evaluate the safety, tolerability and any potential QT prolongation after a single oral administration of 150mg of the studied drug under fasted and fed conditions in healthy adult subjects. The study treatments were well tolerated and no subjects were discontinued from study participation because of adverse events.
No serious adverse events were reported during the study. The phase 1 clinical data also suggested that any QT interval after oral administration of SACT-1 at 150mg was well within clinically acceptable limits. Regarding the relative bioavailability under the Fed vs Fasted condition, the AUC0-tlast, AUC0-8 and Cmax ratio of SACT-1 were determined to be 189.87%, 189.43%, and 205.25% respectively.
