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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164876
• Other study ID #: AUT031206
• Status: Completed
• Phase: Phase 1
• Start date: April 20, 2017
• Est. completion date: April 3, 2019

Study information

• Verified date: July 2020
• Source: Autifony Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 3, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• AUT00206
4 capsules of 200mg AUT00206, twice daily, to take orally with food for 4 weeks
• Placebo
4 capsules of placebo, twice daily, to take orally with food for 4 weeks

Locations

Country	Name	City	State
United Kingdom	King's College London Institute of Psychiatry, Psychology and Neuroscience (IoPPN)	London

Sponsors (2)

Lead Sponsor	Collaborator
Autifony Therapeutics Limited	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo		28 days
Primary	Plasma concentrations of AUT00206		28 days