Safety, Blood Levels and Effects of AUT00201

The study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. It is not clear what causes schizophrenia, but it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will activate specific sites in the brain to help correct that imbalance. Current treatments for schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that the study medicine will work better, and have fewer side effects than existing medicines.

In this 2 part study (Part A: up to 40 healthy male subjects and up to 8 healthy female subjects, Part B: up to 32 healthy male subjects) the primary aim is to assess how safe the study medicine is in healthy men and women.

This study will be in 2 parts, as follows:

Part A will assess single doses of AUT00201 and Part B will assess multiple doses. Part A will be divided into 3 sub-parts: Part A1 will assess single ascending doses in healthy men, Part A2 will assess single ascending doses in healthy women, and Part A3 will assess the effect of food on the PK of AUT00201 in healthy men.

A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will take place at 1 centre in London.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Normotensive male (all groups except Part A2) or female (Part A2 only) volunteers
Must have body mass index (BMI) of 18.0-31.0 kg/m2
Must be healthy based on clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
Must be able to give fully informed written consent.

Exclusion criteria

History or presence of

Epilepsy
Severe head injury, or any other chronic neurological condition or any psychiatric disorder
Abnormal screening EEG (Part A1 and Part B only)
Positive tests for hepatitis B & C, HIV
Severe adverse reaction to any drug
Sensitivity to trial medication
Drug or alcohol abuse
Use of over-the-counter medication within previous 7 days (with the exception of Paracetamol [acetaminophen])
Prescribed medication during previous 28 days
Participation in other clinical trials of unlicensed medicines
Loss of more than 400 mL blood, within the previous 3 months
Vital signs or QTcF interval outside the acceptable range
Clinically relevant abnormal findings at the screening assessment
Acute or chronic illness
Clinically relevant abnormal medical history or concurrent medical condition
Positive result for suicidal ideation or behaviour using the Colombia suicide severity rating scale (C-SSRS)
Possibility that volunteer will not cooperate
Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception

Treatment and study plan

AUT00201

Drug

Oral dose of AUT00201

Placebo

Drug

Oral dose of placebo

Primary outcomes

Percent of subjects with treatment-related adverse events

Time frame: Study Duration (2 weeks post last dose)

Sponsors and collaborators

Lead sponsor

Autifony Therapeutics Limited

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled, Single and Repeated Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AUT00201 in Healthy Male and Female Volunteers

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Nov 8, 2019
Registry last updated: Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed