To investigate safety of Prasugrel in healthy & sickle cell patients

• Research type

  Research Study

• Full title

  A Pharmacokinetic and Pharmacodynamic Assessment of Prasugrel in Healthy Adults and Adults with Sickle Cell Disease

• IRAS ID

  54768

• Contact name

  Tim Mant

• Eudract number

  2010-020056-65

• Research summary

  The drug being tested in this trial is Prasugrel. It is hoped that Prasugrel, which is already used in some patients with coronary artery disease will be effective in reducing the painful crises that occur in patients with sickle cell disease. . In this study we are aiming to find out how safe and tolerable Prasugrel is and how it is broken down and eliminated by the body in Sickle Cell Disease (SCD) volunteers by comparing with healthy volunteers. We will also assess the performance of platelet function in blood from adults with SCD. In a sickle cell crisis platelets clump together. Platelets are very small cell particles that clump together to form a blood clot (thrombus). Prasugrel helps prevent platelet clumping 12 Volunteers with Sickle Cell disease and 12 healthy volunteers will participate in the study. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. The study will last for approximately 7 weeks. The information gained in this study will help the sponsor to determine whether Prasugrel is suitable for further studies in sickle cell volunteers.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/48

• Date of REC Opinion

  28 Jun 2010

• REC opinion

  Further Information Favourable Opinion