QBR110097 (GK1-PK-111)

• Research type

  Research Study

• Full title

  A FOUR-WAY, NON-RANDOMIZED, STUDY TO ASSESS THE ABSOLUTE AND REGIONAL BIOAVAILABILITY OF GK1-399 IN HEALTHY MALE SUBJECTS

• IRAS ID

  65848

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Forest Research Institute, Inc

• Research summary

  Type 2 diabetes is characterized by insulin resistance, impaired insulin secretion, inappropriate liver sugar production, and low blood sugar. The pathophysiology is multifactorial with involvement of genetic and lifestyle/environmental factors. Optimal blood sugar control is the treatment goal in subjects with type 2 diabetes, since the risk of long-term complications is associated with poor control. There have been four completed Phase I clinical studies to date, and there is an ongoing Phase I study in patients, evaluating safety and tolerability. The primary objectives of this study are to: Determine the amount of GK1-399 in the blood via intravenous administration. Determine the amount of GK1-399 in the blood after direct administration to two sites in the small intestine and one site in the large intestine.The amount of drug entering the bloodstream will be assessed from each location and compared with that for an orally administered immediate release formulation.The secondary objective is to provide additional safety and tolerability information on GK1-399.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/25

• Date of REC Opinion

  5 Jan 2011

• REC opinion

  Further Information Favourable Opinion