Thorough QT study of imeglimin, version 1
Research type
Research Study
Full title
A randomised, double-blind, placebo- and active-controlled crossover study to assess the effect of single dose administration of 2 doses of imeglimin on QT/QTc intervals in healthy subjects (16-013)
IRAS ID
207659
Contact name
Adeep Puri
Contact email
Sponsor organisation
Poxel SA
Eudract number
2016-001821-14
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
Imeglimin (the study medicine) is an experimental treatment for type 2 diabetes. People with diabetes have high blood sugar. If diabetes isn’t treated, it can cause long-term health problems owing to high blood sugar. Previous studies have shown that imeglimin reduces blood sugar.
When developing new medicines, it’s important to test for any effect on the heart. We do that using electrocardiograms (ECGs), which painlessly record the electrical activity of the heart. The main aim of this study is to find out if single doses of imeglimin have any effect on ECGs.
To make sure that the study can detect any effects on ECGs that imeglimin might cause, we’ll also give participants a single dose of moxifloxacin — an antibiotic that causes small and short-lived changes in ECGs. Moxifloxacin is a marketed medicine, which can be prescribed by doctors.
We’ll recruit 52 healthy men and women, aged 18–45 years. Each participant will have 4 study sessions, in which they’ll take a single dose of imeglimin (2 different dose levels), moxifloxacin or dummy medicine. Each participant will take all 4 treatments (1 per study session). Imeglimin and the dummy medicine look the same, so neither the participants nor we will know which one they’re taking (but we could find out if necessary). Moxifloxacin looks different, so we’ll know when they’re taking it.
Participants will take up to 7 weeks to finish the study. Each participant will have: a screening visit; 4 study sessions, each lasting 2 nights; and a final follow-up visit.
A pharmaceutical company (Poxel SA) is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
16/NI/0121
Date of REC Opinion
15 Jul 2016
REC opinion
Further Information Favourable Opinion