Safety/tolerability/PK of GRC8200 in healthy young & elderly subjects

• Research type

  Research Study

• Full title

  A single-centre, study to assess the safety, tolerability and pharmacokinetics of a new oral DPP IV (Dipeptidyl peptidase IV) inhibitor, GRC 8200 (melogliptin mesylate), after single dose on healthy young and healthy elderly male and female volunteers.

• IRAS ID

  32253

• Contact name

  Ravin Bathula

• Sponsor organisation

  Glenmark Pharmaceuticals Ltd.

• Eudract number

  2009-015788-14

• 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 SA (The Sponsor) is absorbed, distributed, broken down and excreted (pharmacokinetics) when given as a single dose to healthy young and healthy elderly male and female volunteers. The group of drugs to which GRC 8200 (melogliptin mesylate) belongs is known as DPP-IV inhibitors, this group of drugs act by blocking the action of a gut hormone to reduce blood sugar levels. The aim of this study is to collect pharmacokinetic and safety data to allow further development of the study drug. Twenty-four volunteers will be enrolled: 12 healthy elderly (=65 years) and 12 healthy young (=18 - =45 years) volunteers. The young population will be matched with the elderly population for sex (gender) and body mass index ( 20%).

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  09/S1401/85

• Date of REC Opinion

  11 Dec 2009

• REC opinion

  Favourable Opinion