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

NCT03164876 | Completed Phase 1

• 1 other identifier: AUT031206
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Dose AUT00206 800 mg BD

EXPERIMENTAL

AUT00206 800mg twice daily for 28 days

Drug: AUT00206

Placebo

PLACEBO COMPARATOR

Placebo to match AUT00206 twice daily for 28 days

Drug: Placebo

Interventions

AUT00206 DRUG

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

Dose AUT00206 800 mg BD

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Male 18-50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• objection by subject's physician

Sponsors & Collaborators

• Autifony Therapeutics Limited: lead
• King's College London: collaborator

Study Sites (1)

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

London, United Kingdom

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 24, 2017
• Study Start: April 20, 2017
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)