drugset / Trial / NCT03164876

Safety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.

NCT03164876

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug.

Timeline

Start
2017-04-20
Primary completion
2019-04-03
Completion
2019-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject AUT00206 Small molecule 800 mg Oral

Indications