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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Double-blind, Placebo-controlled Study of the Safety, Pharmacokinetics and Exploratory Pharmacodynamics of AUT00206 for 28 Days as Adjunctive Therapy in Patients With Recently Diagnosed Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: AUT00206
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key inclusion Criteria: Male patients with a diagnosis of schizophrenia no more than 5 calendar years (before screening); Positive and negative symptoms assessed by PANSS; Medically and psychiatrically stable; On a stable dose of antipsychotic drugs; Able to give fully informed written consent and likely to comply with the requirements of the trial. Key exclusion Criteria: clinically relevant, as assessed by a physician, abnormal findings at the screening assessment; sensitivity to excipients of the trial medication; current use of contraindicated drugs; participation in another clinical trial of unlicensed medicines within the previous 30 days; loss of more than 400 mL blood, within the previous 3 months; history of drug or alcohol dependence in the last year; significant acute or chronic illness; significant medical history or concurrent medical condition that warrants exclusion; objection by subject's physician

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose AUT00206 800 mg BD<br>AUT00206 800mg twice daily for 28 days | Drug: AUT00206<br>* 4 capsules of 200mg AUT00206, twice daily, to take orally with food for 4 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo to match AUT00206 twice daily for 28 days | Drug: Placebo<br>* 4 capsules of placebo, twice daily, to take orally with food for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo |  | 28 days | 
| Plasma concentrations of AUT00206 |  | 28 days |