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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03164876
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Autifony Therapeutics Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: AUT00206 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male 18-50 Years
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164876


Locations
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United Kingdom
King's College London Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
London, United Kingdom
Sponsors and Collaborators
Autifony Therapeutics Limited
King's College London
More Information
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Responsible Party: Autifony Therapeutics Limited
ClinicalTrials.gov Identifier: NCT03164876    
Other Study ID Numbers: AUT031206
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders