Alkermes plc announced the initiation of a phase 1 clinical study of ALKS 7119, an oral, investigational drug candidate being developed for the treatment of agitation in patients with the company's disease (AD) and other central nervous system (CNS) indications. The double-blind, placebo-controlled study will evaluate the safety and tolerability of single ascending doses of ALKS 7119 in approximately 60 healthy subjects. ALKS 7119 is a novel small molecule that acts on multiple key receptor systems in the brain.

The randomized, double-blind, placebo-controlled, multi-cohort, phase 1 study will investigate the safety and tolerability of single ascending doses of ALKS 7119 following oral administration in approximately 60 healthy male adults. The study will also include a battery of psychometric assessments, which are intended to provide preliminary insight into the potential human pharmacodynamic response. Results from this phase 1 study are expected in the second half of 2016.