Safety, blood levels and effects of AUT00206, version 1
Research type
Research Study
Full title
A randomised, double-blind, placebo controlled, single and repeated dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AUT00206 in healthy volunteers 15-005
IRAS ID
182690
Contact email
Eudract number
2015-002364-16
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. We’re not sure what causes
schizophrenia, but it’s been linked to chemical imbalance in the brain. We hope 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. We hope that the study medicine will work better, and have fewer side effects than existing medicines.In this 2-part study (Parts A and B), we primarily aim to assess how safe the study medicine is in healthy men, aged 18–45 years, and how much of it gets into the blood. We’ll also test its effects on the brain.
In Part A, we’ll give up to 24 participants up to 5 single doses of the study medicine by mouth, either after fasting or after a high-fat breakfast. The study medicine has never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. Participants may take up to 14 weeks to finish the study. They’ll make up to 22 outpatient visits, and stay on the ward up to 5 times, for 3 nights in a row each time.
In Part B, we’ll give 24 participants daily doses of the study medicine for up to 28 days. Participants will take up to 10 weeks to finish the study. They’ll make 6 outpatient visits, and stay on the ward for up to 30 nights, depending on how long we expect it to take until blood levels of the study medicine level off.
A pharmaceutical company, Autifony Therapeutics Limited, is funding the study.
The study will take place at 1 centre in London.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0970
Date of REC Opinion
1 Sep 2015
REC opinion
Further Information Favourable Opinion