Safety and blood levels of imeglimin in Japanese volunteers; version 1

• Research type

  Research Study

• Full title

  A phase 1, randomised, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of imeglimin in healthy Japanese subjects (14-027)

• IRAS ID

  167525

• Contact name

  Adeep Puri

• Contact email

  rec@hmrlondon.com

• Sponsor organisation

  Poxel SA

• Eudract number

  2014-004679-21

• Duration of Study in the UK

  1 years, 1 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. Previous studies have shown that imeglimin reduces blood sugar.
  
  If this and future studies are successful, imeglimin would be a useful treatment for patients in many countries, including Japan. But first we need to test it in healthy Japanese people, so we can compare the results with those from other ethnic groups. We’re doing this study to find out the blood levels and side effects of imeglimin in healthy Japanese people, aged 20-45 years.

  The study is in 2 parts. In Part A, we’ll give 24 Japanese participants, single and twice-daily doses of imeglimin. We’ll start with a low dose and increase the dose as the study progresses. Participants will stay on the ward for 13 nights.

  The design of Part B depends on the results of Part A – we’ll choose from the following options:
  • Part B1 – we’ll test additional dose levels, as in Part A, in up to 16 Japanese participants.
  • Part B2 – we’ll test higher single doses of imeglimin in up to 48 healthy Japanese and/or Caucasian participants. They’ll stay on the ward for 4 nights.
  • Part B3 – we’ll give up to 8 Japanese participants 2 single doses of imeglimin: once on an empty stomach, and once after a fatty breakfast. They’ll have 2 study sessions each lasting 4 nights.

  Participants will have a follow-up visit or telephone call, depending on their dose.

  In each part of the study participants might take placebo instead of imeglimin. Neither the participants nor we will know which treatment they’re taking.

  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

  14/LO/1993

• Date of REC Opinion

  18 Dec 2014

• REC opinion

  Favourable Opinion