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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03164876

Enrollment

Registered

2017-05-24

Start date

2017-04-20

Completion date

2019-04-03

Last updated

2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

DRUGAUT00206

4 capsules of 200mg AUT00206, twice daily, to take orally with food for 4 weeks

DRUGPlacebo

4 capsules of placebo, twice daily, to take orally with food for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026