The effect of cimetidine on the PK of imeglimin, version 1
Research type
Research Study
Full title
An open-label, one-sequence study to assess the effect of repeated oral doses of cimetidine on the single dose pharmacokinetics, safety and tolerability of imeglimin in healthy Caucasian subjects. (HMR code: 18-005)
IRAS ID
245741
Contact name
Adeep Puri
Contact email
Eudract number
2018-001103-36
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
Imeglimin 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.
In healthy people, blood sugar is decreased by a hormone called insulin, which is made by the pancreas. People develop type 2 diabetes when their pancreas can’t make enough insulin, or when their insulin doesn’t work properly, so their blood sugar is high.
Previous studies have shown that imeglimin reduces blood sugar by increasing the amount of insulin made by the pancreas. So far, imeglimin has been safe and well tolerated. At the highest doses, the most common side-effects have been abdominal pain, nausea and diarrhoea.
Imeglimin is removed from the body by substances called ‘transporters’ in the kidneys. Sometimes, when you take 2 medicines together, your body takes longer to get rid of one or both of them. We’re doing this study, in healthy people, to find out whether blocking certain transporters in the kidney, using a test medicine called cimetidine, affects the way the body handles imeglimin. If imeglimin is removed more slowly when taken with cimetidine, there might be more side effects.
16 healthy Caucasian men and women, aged 18–55 years, will have 1 study session. First, they’ll take a single dose of imeglimin on its own. Then they’ll take cimetidine each morning and evening for 6 days. On the fourth day of taking cimetidine, they’ll also take a dose of imeglimin in the morning.Participants will take 2.5 weeks to finish the study. Each participant will have: a screening visit in the 4 weeks before they start the study; a study session lasting 11 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
London - Harrow Research Ethics Committee
REC reference
18/LO/0654
Date of REC Opinion
14 May 2018
REC opinion
Favourable Opinion