fMRI study of ABX-1431
Research type
Research Study
Full title
An fMRI study in healthy volunteers to investigate the effects of ABX-143 on experimental hyperalgesia and its neural correlates.
IRAS ID
193324
Contact name
Irene Tracey
Contact email
Sponsor organisation
Abide Therapeutics
Eudract number
2016-002150-21
Duration of Study in the UK
1 years, 1 months, 2 days
Research summary
An fMRI study in healthy volunteers to investigate the effects of ABX-1431 on experimental hyperalgesia and its neural correlates.
This study aims to determine the effect of a novel compound on neural pain mechanisms. Chronic pain is a common condition that remains difficult to treat, and the development of new drugs for this condition is of huge importance. ABX-1431 HCl is a drug that acts through the cannabinoid pathway. Animal models have shown promising effects on pain behaviours, and so far human trials have not identified any safety issues. By elucidating the effects of the drug on hyperalgesia (hypersensitivity to pain), and measuring changes in brain activity due to the drug, we hope to demonstrate that the drug shows promise as a treatment for pain.
A randomised, controlled, partially-blinded crossover design will be used. We aim to recruit 16 healthy volunteers aged 18-55, each of whom will complete 5 visits to the Centre for Functional MRI of the Brain (FMRIB) at the John Radcliffe Hospital, Oxford. Visit 1 will involve eligibility assessment and baseline measures. During visits 2-4, capsaicin cream (the active component of chilli peppers) will be applied to cause temporary hypersensitivity of the skin. We will measure the effect of the drug on this hypersensitvity and will also measure the associated changes in brain activity using functional MRI. This will be compared to the effects of placebo and of no intervention. Visit 5 is a follow-up visit. The study is funded by Abide Therapeutics and the Oxford BRC.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0404
Date of REC Opinion
21 Aug 2016
REC opinion
Favourable Opinion