NCT02589262

Safety, Blood Levels and Effects of AUT00206

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Autifony Therapeutics Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 (Parts A and B), the primary aim is to assess how safe the study medicine is in healthy men, aged 18-45 years, and how much of it gets into the blood. Its effects on the brain will also be tested. In Part A, up to 24 participants will receive up to 5 single doses of the study medicine (AUT00206 or placebo) by mouth, either after fasting or after a high fat breakfast. The study medicine has never been given to humans before, so the initial doses will be small and the dose level will be increased 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, 24 participants will receive daily doses of the study medicine (AUT00206 or placebo) 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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	AUT00206

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-10-28
• Last updated: 2016-10-14

Locations

1 site across 1 country: United Kingdom