Investigation of GMC-252 in Healthy Volunteers and Type 2 Diabetics

• Research type

  Research Study

• Full title

  A double blind, placebo-controlled, randomised, multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of GMC-252 in healthy male subjects and male type 2 diabetics.

• IRAS ID

  206762

• Contact name

  R Adams

• Sponsor organisation

  Genmedica Therapeutics S.L.

• Eudract number

  2015-005708-27

• Clinicaltrials.gov Identifier

  NCT02686281

• Duration of Study in the UK

  0 years, 6 months, 0 days

• Research summary

  The purpose of this study is to investigate a drug called GMC-252 and to assess the the safety of this drug when different amounts are given. The study will also look at how quickly GMC-252 enters the bloodstream, is distributed in the blood, broken down and disposed of by the body after it is taken daily for 28 days. Whilst the aim of this study is to perform these assessments in both healthy males and type 2 diabetic, the present application is only for the study in healthy males.

  GMC-252 is being developed for the treatment of Type 2 diabetes mellitus. The study is to find out how much of GMC-252 (the dose) should be given to patients with Type 2 diabetes mellitus.
  Part 2 of this study will be carried out in 1 cohort of 15 type 2 diabetic patients.
  

• REC name

  Wales REC 1

• REC reference

  16/WA/0151

• Date of REC Opinion

  13 Jun 2016

• REC opinion

  Further Information Favourable Opinion