Phase 1, PK, Food Effect Study of a Novel Formulation of PSN821

• Research type

  Research Study

• Full title

  An Open, Phase I, Randomised, Three Way Cross Over, Food Effect and Bioavailability Study of A Novel Formulation of PSN821 (Compared to Suspension) in Healthy Male Subjects.

• IRAS ID

  72400

• Contact name

  Pui Man Leung

• Sponsor organisation

  (OSI) Prosidion Limited

• Eudract number

  2011-000034-11

• ISRCTN Number

  1

• Research summary

  The drug that is being tested is PSN821 which is being developed to treat Type 2 Diabetes. Type 2 diabetes causes high blood glucose levels and has been linked with being overweight. Current treatments for Type 2 Diabetes can have intolerable side effects, only partial Effectiveness or need to be given by injection. Therefore a need exists for an oral treatment for Type 2 diabetes that is highly effective but results in fewer side effects. PSN821 is being developed to address this need. Previous clinical studies carried out with PSN821 have shown it to be safe and well tolerated at doses of up to 3000mg. The purpose of this study is to look at how much PSN821 gets into the blood stream when taken as a liquid (suspension) and as a capsule. We will also be looking to see if the amount of PSN821 taken into the blood is affected by food. We will do this by taking blood samples to measure the levels of PSN821 in the blood When subjects have received PSN821 before eating (fasted) and 5 minutes after they have finished a high fat, fried breakfast (fed).If we need to we may also ask subjects to come back to look at the levels of PSN821 in the blood 5 minutes after they have finished a light breakfast. This will allow us to know whether it is better to give PSN821 before or after food.

• REC name

  Wales REC 2

• REC reference

  11/WSE02/5

• Date of REC Opinion

  11 Feb 2011

• REC opinion

  Favourable Opinion