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

Sponsor

Autifony Therapeutics Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT03164876

Collaborator

King's College London (Other)

Enrollment

Location

Arms

23.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Apr 20, 2017

Actual Primary Completion Date :

Apr 3, 2019

Actual Study Completion Date :

Apr 3, 2019

Arms and Interventions

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

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

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

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

Sponsors and Collaborators

Autifony Therapeutics Limited
King's College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Autifony Therapeutics Limited

ClinicalTrials.gov Identifier:

NCT03164876

Other Study ID Numbers:

AUT031206

First Posted:

May 24, 2017

Last Update Posted:

Jul 31, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of Jul 31, 2020