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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose AUT00206 800 mg BD
AUT00206 800mg twice daily for 28 days
Intervention: AUT00206 (Drug)
Placebo
Placebo to match AUT00206 twice daily for 28 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo
Time Frame: 28 days
Plasma concentrations of AUT00206
Time Frame: 28 days
Secondary Outcomes
No secondary outcomes reported