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

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 Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: AUT00206; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • King's College London Institute of Psychiatry, Psychology and Neuroscience (IoPPN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Autifony Therapeutics Limited
• Collaborators: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): April 3, 2019

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: AUT031206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No