PK and Metabolism of GLPG0634 in Healthy Male Subjects (QBR114504)

• Research type

  Research Study

• Full title

  Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects Following a Single Oral Administration of [14C] GLPG0634

• IRAS ID

  121286

• Contact name

  Philip Evans

• Sponsor organisation

  Galapagos NV

• Eudract number

  2012-003254-88

• ISRCTN Number

  To be applied for

• Research summary

  The study drug (GLPG0634) is being developed for the treatment of inflammatory diseases such as Rheumatoid Arthritis. This is a disease with common symptoms of inflammation and joint deterioration. The disease affects almost 1% of the adult population worldwide and is characterised by pain, stiffness and restricted movement due to long lasting inflammation of multiple joints. The purpose of this study is to investigate how the study drug is taken up and broken down by the body when given orally (by mouth) in a solution. The study drug is radiolabelled to study this. ??Radiolabelled?? means that the test drug has a radioactive component which helps us to track where the drug is in the body. The safety and tolerability of the test drug will also be assessed. 6 subjects will be enrolled in this study. Each subject will receive a single oral dose of 100 mg [14C]-GLPG0634 as an oral solution.

• REC name

  Wales REC 1

• REC reference

  13/WA/0008

• Date of REC Opinion

  30 Jan 2013

• REC opinion

  Further Information Favourable Opinion