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

NCT ID: NCT03164876

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2019-04-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dose AUT00206 800 mg BD

AUT00206 800mg twice daily for 28 days

Group Type: EXPERIMENTAL

AUT00206

Intervention Type: DRUG

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

Placebo

Placebo to match AUT00206 twice daily for 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

AUT00206

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Autifony Therapeutics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

AUT031206

Identifier Type: -

Identifier Source: org_study_id