Safety, Tolerability and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients

This study is designed as a three-part trial to evaluate the safety of a novel depot
formulation of iloperidone, compare two depot dosage forms, and perform dose ranging of one
chosen form in support of a monthly depot dosing regimen. In Phase A, the study is designed
to evaluate the safety of a crystalline iloperidone depot formulation. In Phase B, the
pharmacokinetic and safety profile of two depot clinical dosage forms will be compared, and
one form will be selected for assessment in Phase C. Phase C of this study is designed to
define the dose-exposure relationship of the selected form and to provide information that
will permit a comparison of the risk-benefit ratio of several doses of the study drug to
enable optimal dose selection for later studies.