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Completed

NCT Number: NCT03164876

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AUT00206

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo

    Time frame: 28 days

  2. Plasma concentrations of AUT00206

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Autifony Therapeutics Limited

Industry

Collaborators

  • King's College London

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 24, 2017
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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