Oral bioavailablity and ADME of [14-C]-S-555739 (QBR113532)

• Research type

  Research Study

• Full title

  An Open-Label, Single Dose Study Designed to Assess Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-S-555739 in Healthy Male Subjects

• IRAS ID

  116392

• Contact name

  Stuart Mair

• Sponsor organisation

  Shionogi & Co. Ltd

• Eudract number

  2012-004512-55

• ISRCTN Number

  to be registered

• Research summary

  S-555739 is being developed by Shionogi & CO., LTD for the treatment of allergic rhinitis, which is an allergic inflammation of the nasal airways. It occurs when an allergen, such as pollen, dust or animal dander (particles of shed skin and hair) is inhaled by an individual with a sensitized immune system. When caused by grass pollens, it is known as "hay fever". The purpose of the study is to measure how radiolabelled S-555739 is taken up, broken down and removed from the body when given orally (by mouth) as a thick drink. ??Radiolabelled?? means that the study drug has a radioactive component which helps us to track where the drug is in the body. In this study 8 male healthy volunteers will receive a single oral dose of 100 mg radiolabelled S-555739. Blood, urine and faecal samples will be collected at specific times throughout the study to measure amounts of the drug in the body. The safety and tolerability of the study drug will also be assessed.

• REC name

  Wales REC 1

• REC reference

  12/WA/0328

• Date of REC Opinion

  21 Nov 2012

• REC opinion

  Further Information Favourable Opinion