Thorough QT study of Evenamide
Research type
Research Study
Full title
A Phase 1, randomized, partially-blinded, placebo-controlled, and positive-controlled (moxifloxacin), 4 way cross-over study to assess the effect of single doses of evenamide (NW-3509) on the QT/QTc interval in healthy subjects
IRAS ID
1003340
Contact name
Temitope Adeloye
Contact email
Eudract number
2020-003113-35
Research summary
Evenamide is an experimental treatment for schizophrenia, an illness that affects the way\npeople think, feel, or behave. We’re not sure what causes schizophrenia, but it’s been\nlinked to chemical imbalances in the brain. We hope that the study medicine will help to\ncorrect those chemical imbalances. We hope that when evenamide is given with existing\ntreatments, it will make them more effective.\nWhen developing new medicines, it’s important to test for any effect on the heart. We do\nthat using electrocardiograms (ECGs), which painlessly record the electrical activity of\nthe heart. The main aim of this study is to find out if evenamide has any effect on the\nheart.\nTo make sure that the study can detect any effects on ECGs that evenamide might cause,\nwe’ll also study a single dose of moxifloxacin – an antibiotic that causes small and\nshort-lived changes in ECGs. Moxifloxacin is a marketed medicine, which means that it\ncan be prescribed by doctors.\nWe’ll recruit 56 healthy men and women, aged 18–55 years. Each participant will have\n4 study sessions. In each study session, they’ll take a single dose of evenamide (2\ndifferent dose levels), dummy medicine or moxifloxacin. Each participant will take all 4\ntreatments (1 per study session). Evenamide and the dummy medicine look the same, so\nneither the participants nor HMR will know which one they’re taking. Moxifloxacin\nlooks different, so we’ll know when they’re taking it.\nParticipants will take up to 8 weeks to finish the study. Each participant will have: a\nscreening visit; 4 study sessions, each lasting 2 nights; and a final follow-up visit.\nA pharmaceutical company (Newron Pharmaceuticals S.p.A) is funding the study.\nThe study will take place at 1 centre (HMR) in London.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0881
Date of REC Opinion
11 Aug 2020
REC opinion
Further Information Favourable Opinion