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Objectives  Safety, tolerability, pharmacokinetics, and pharmacodynamics of a novel β‐site amyloid precursor protein cleaving enzyme 1 (BACE1) inhibitor, JNJ‐54861911, were assessed after single and multiple dosing in healthy participants.    Methods  Two randomized, placebo‐controlled, double‐blind studies were performed using single and multiple ascending JNJ‐54861911 doses (up to 14 days) in young and elderly healthy participants. Regular blood samples and frequent CSF samples, up to 36 hours after last dose, were collected to assess the pharmacokinetic and pharmacodynamic (Aβ, sAPPα,β,total levels) profiles of JNJ‐54861911.    Results  JNJ‐54861911 was well‐tolerated, adverse events were uncommon and unrelated to JNJ‐54861911. JNJ‐54861911 showed dose‐proportional CSF and plasma pharmacokinetic profiles. Plasma‐ and CSF‐Aβ and CSF‐sAPPβ were reduced in a dose‐dependent manner. Aβ reductions (up to 95%) outlasted exposure to JNJ‐54861911.  APOE  ε4 carrier status and baseline Aβ levels did not influence Aβ/sAPPβ reductions.    Conclusion  JNJ‐54861911, a potent brain‐penetrant BACE1 inhibitor, achieved high and stable Aβ reductions after single and multiple dosing in healthy participants.

Profiling the dynamics of CSF and plasma Aβ reduction after treatment with JNJ‐54861911, a potent oral BACE inhibitor