Schizophrenia Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled, Single Ascending Dose Study With Lurasidone Injectable Suspension to Evaluate Safety, Tolerability and Pharmacokinetics in Subjects With Schizophrenia
A study to determine the maximum tolerated dose of an investigational drug in subjects with schizophrenia
This is a single-center, randomized, double-blind, placebo-controlled, inpatient, single ascending dose (SAD) study designed to evaluate the safety, tolerability, and PK of lurasidone injectable suspension in subjects with schizophrenia. This study will determine the minimum intolerable dose (MID), the maximum tolerated dose (MTD) of lurasidone injectable suspension, and characterize the PK profiles of lurasidone and its metabolites in serum (ID-14283, ID-14326, ID-11614, ID-20219, and ID-20220) and urine (ID-14283, ID-14326, and ID-11614) in this subject population. The potential effects of gender on the PK of lurasidone injectable suspension and its metabolites will also be evaluated when applicable. ;
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