PK of upto 6 Modified-Release Prototypes of Apremilast CC-10004-CP-021

• Research type

  Research Study

• Full title

  A 2-PART PHASE 1, OPEN-LABEL STUDY IN HEALTHY MALE SUBJECTS TO EVALUATE THE PHARMACOKINETICS OF APREMILAST (CC 10004) FROM UP TO 6 PROTOTYPE MODIFIED-RELEASE (MR) FORMULATIONS AND TO ASSESS THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF A SELECTED MR PROTOTYPE

• IRAS ID

  94719

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2011-004473-81

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The study drug, Apremilast, is under clinical development for the treatment of inflammatory autoimmune disorders which are characterized by the body's immune responses being directed against its own tissues, causing prolonged inflammation. This study is in 2 parts. In Part A, the pharmacokinetics (PK) and bioavailability (how well the drug is absorbed into the bloodstream and how quickly it is broken down) of 5 prototype modified release (MR) formulations of Apremilast will be evaluated against an existing immediate release (IR) formulation. If at least one MR prototype demonstrates suitable PK and bioavailability, then one of the 5 prototypes will be evaluated in Part B, for the effect of food on bioavailability.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  12/EE/0015

• Date of REC Opinion

  7 Feb 2012

• REC opinion

  Further Information Favourable Opinion