QBR104322 (D4280C00008)

• Research type

  Research Study

• Full title

  An Open Label Single-Dose Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite profile and Metabolite Identification of [14C]NXL104

• IRAS ID

  82686

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2011-002525-21

• Research summary

  NXL104 is being developed by AstraZeneca as a treatment of infections when taken with antibacterial medicines. It is specifically intended for the treatment of a variety of urinary tract infections which have become resistant to other available medicines.The purpose of the study is to look at how radiolabelled NXL104 is taken up, broken down and removed by the body when given as an injection into the blood stream. ??Radiolabelled? means that the test drug has a radioactive addition which allows us to track the drug. Blood, urine and faeces samples will be taken from volunteers at specific times throughout the study to look at the concentrations of drug in the body. The safety and tolerability of the test drug will also be assessed.

• REC name

  Scotland A REC

• REC reference

  11/IE/0091

• Date of REC Opinion

  4 Jul 2011

• REC opinion

  Further Information Favourable Opinion