Phase 1 drug interaction study of Ketoconazole and PSN821

• Research type

  Research Study

• Full title

  An Open, Phase I, Randomised, Two Way Cross Over, Ketoconazole-PSN821 Interaction Study in Healthy Male Subjects

• IRAS ID

  97970

• Contact name

  Pui Man Leung

• Sponsor organisation

  Prosidion Limited

• Eudract number

  2011-005824-16

• Clinicaltrials.gov Identifier

  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. The purpose of the study is to investigate how blocking an enzyme in the body called CYP 3A4 affects blood levels of PSN821. This enzyme is responsible for the breakdown of drugs in the body. Researchers believe that CYP3A4 is the enzyme responsible for the breakdown of the study drug. In this study ketoconazole will be given to block the action of CYP 3A4. During the study ketoconazole and PSN821 will be given at one visit and PSN821 alone in another visit. Blood samples will be collected throughout each visit so that we can measure the levels of study drug with and without ketoconazole being present.

• REC name

  Wales REC 2

• REC reference

  12/WA/0005

• Date of REC Opinion

  19 Jan 2012

• REC opinion

  Favourable Opinion