Safety, Blood Levels and Effects of AUT00201

NCT04158453 | Completed Phase 1

• 1 other identifier: AUT011201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Percent of subjects with treatment-related adverse events

  Study Duration (2 weeks post last dose)

Study Arms (2)

AUT00201

ACTIVE COMPARATOR

Drug: AUT00201

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AUT00201 DRUG

Oral dose of AUT00201

AUT00201

Placebo DRUG

Oral dose of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Autifony Therapeutics Limited: lead

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, 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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 8, 2019
• Study Start: October 10, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 24, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)