Safety, tolerabilty & PK of GRC8200 in subjects with renal impairment

• Research type

  Research Study

• Full title

  Safety, tolerability and pharmacokinetics of a new oral DPP IV inhibitor (Dipeptidyl peptidase IV) GRC 8200 (melogliptin mesylate), in male and female subjects with severe, moderate and mild renal impairment and age, race, sex and body mass index matched healthy volunteers.

• IRAS ID

  32396

• Contact name

  Ronnie Beboso

• Sponsor organisation

  Glenmark Pharmaceuticals Ltd.

• Eudract number

  2009-015789-80

• Research summary

  The main purpose of the study is to assess how a new investigational drug called GRC-8200 (melogliptin mesylate) manufactured by Glenmark Pharmaceuticals (The Sponsor) is absorbed, distributed, broken down and eliminated by the body (pharmacokinetics) when given as a single dose in patients with reduced kidney function (renal impairment) and compared to healthy volunteers matched for age, race and body mass index. GRC 8200 aims to increase the levels of a hormone (insulin) that controls the secretion of sugar or glucose produced in the gut in order to prevent abnormally large amounts of sugar in the blood (hyperglycaemia) in patients with a disorder where there is a deficiency of insulin making the body unable to process and use sugar (Type 2 diabetes mellitus). A common co-existing condition to Type 2 Diabetes is reduced kidney function (renal impairment); therefore this study aims to confirm that severe renal impairment does not alter what the drug is designed to do to the body.This is a two-part study that will potentially involve 32 volunteers. In part 1, sixteen male and female volunteers will be given a single 50mg oral dose of GRC 8200, of which 8 will be healthy and 8 will be diagnosed with severe renal impairment, otherwise healthy. If the results of this study indicate that severe renal impairment does not alter the drug's pharmacokinetics, no further testing will be required.If the pharmacokinetics of GRC 8200 is significantly altered in those with severe renal impairment, Part 2 of the study will be conducted in a further sixteen subjects, 8 with moderate and 8 with mild renal impairment.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  09/S1401/84

• Date of REC Opinion

  11 Dec 2009

• REC opinion

  Favourable Opinion