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
199231
Contact name
R Adams
Sponsor organisation
Genmedica Therapeutics S.L.
Eudract number
2015-005708-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 9 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.
This study will be carried out in 3 cohorts, the 3 cohorts will each have 7 healthy male volunteers (21 total).REC name
Wales REC 1
REC reference
16/WA/0027
Date of REC Opinion
30 Mar 2016
REC opinion
Further Information Favourable Opinion