Safety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.
Phase 1
Completed
- Conditions
- Schizophrenia
- Interventions
- Drug: AUT00206Drug: Placebo
- Registration Number
- NCT03164876
- Lead Sponsor
- Autifony Therapeutics Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose AUT00206 800 mg BD AUT00206 AUT00206 800mg twice daily for 28 days Placebo Placebo Placebo to match AUT00206 twice daily for 28 days
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
King's College London Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
🇬🇧London, United Kingdom