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news.ARYx Therapeutics has received clearance from the FDA to initiate clinical testing of ATI-9242, a novel antipsychotic for the treatment of schizophrenia and other psychiatric disorders.
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The company has begun dosing healthy volunteers with ATI-9242 in a Phase I safety study being conducted under an investigational new drug application. ARYx expects to complete the Phase I study by the end of 2008.
The current study, CLN-901, is a Phase I, single center, randomized, double-blind, placebo controlled, single ascending dose, safety, tolerability, and pharmacokinetics study. Healthy subjects will be studied in groups of five and will receive ATI-9242 at one dose level or matching placebo. Four of the five subjects in each cohort will be randomly assigned to receive active study medication, and one of the five subjects will be randomly assigned to receive placebo. Each successive group will receive an increased dose of the drug and the dose will continue to be increased until a clear pharmacological effect is observed.
ATI-9242 is designed as a next-generation atypical antipsychotic agent. Its receptor profile is targeted at the treatment of both the positive and the negative symptoms of schizophrenia as well as the improvement of cognitive function. ATI-9242 was also designed to avoid certain drug-drug interactions as well as reduce certain metabolic problems associated with this class of therapy, including weight gain and type 2 diabetes.