Study of the Effect of AUT00206 in healthy male - ketamine challengeV1
Research type
Research Study
Full title
A Phase 1, single-centre, double-blind, placebo-controlled crossover study to assess the pharmacoMRI effects of AUT00206 in healthy male participants
IRAS ID
200753
Contact name
John Francis William Deakin
Contact email
Sponsor organisation
Autifony Therapeutics Limited
Eudract number
2016-000216-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study will explore whether single doses of AUT00206, compared to placebo, modules the effects of ketamine on neural activity in the brains of healthy males. \nThe participants will receive 4 different treatments, at visits separated by 6 to 16 days. During these treatments participants will first take an oral dose of AUT00206 or placebo and 3 hours later they will be given an infusion of either saline or ketamine (a drug which causes mild and transient symptoms that are similar to those seen in patients suffering from schizophrenia).\nThe study will focus on areas of the brain known to be sensitive to ketamine in order to investigate whether AUT00206 is a potential new treatment for schizophrenia. Neural activity will be measured using functional Magnetic Resonance Imaging (fMRI) of the brain.\nHealthy volunteers will attend a screening visit to determine whether they are eligible to enter the study. \nEligible participants will return to the study site for 4 Assessment Visits. During each of the Assessment Visits they will receive one of each of the 4 treatments (placebo + saline infusion; placebo + ketamine infusion; low dose AUT00206 + ketamine infusion; high dose AUT00206 + ketamine infusion). These treatments will be assigned in a random order. During the infusion period they will have an MRI scan, during which they will perform a short computer-based task. They will be discharged from the study site approximately 3 hours after the end of the infusion. \nOnce all 4 Assessment Visits have been completed, participants will return for a follow-up visit to check their general health. The study will last for a maximum of 15 weeks for each participant.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0151
Date of REC Opinion
22 Mar 2016
REC opinion
Favourable Opinion