QCL-1252 (CC-10004-CP-012)

• Research type

  Research Study

• Full title

  A Phase I, Single-Center, Partially Randomized, Open-Label Study to Investigate the Absolute and Regional Bioavailability of Apremilast (CC-10004) in Healthy Subjects

• IRAS ID

  48878

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2009-016224-32

• Research summary

  Apremilast (CC-10004) is an investigational drug that has not yet been approved in any country to treat any medical conditions. It is being investigated as a treatment for inflammatory autoimmune disorder such as psoriatic arthritis, psoriasis, rheumatoid arthritis and BehÇõet disease.The purpose of this study is to measure the amount of Apremilast (CC-10004) in blood when it is given by mouth as a tablet compared with intravenous (into a vein) administration, and when it is given as a solution or particulate within the Enterion?½ capsule and released into 3 different parts of the gut. This will allow us to assess where in the gut the drug is best absorbed.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/6

• Date of REC Opinion

  11 Jun 2010

• REC opinion

  Further Information Favourable Opinion