Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation
of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 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 2 depot clinical dosage forms will be compared, and 1 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.