QBR106411

• Research type

  Research Study

• Full title

  AN OPEN LABEL, SINGLE IV DOSE STUDY IN HEALTHY MALE SUBJECTS DESIGNED TO ASSESS THE MASS BALANCE RECOVERY, METABOLITE PROFILE AND METABOLITE IDENTIFICATION OF 14C DELAFLOXACIN (RX-3341)

• IRAS ID

  78008

• Contact name

  Stuart J Mair

• Sponsor organisation

  Rib-X Pharmaceuticals, Inc

• Eudract number

  2011-000795-34

• Research summary

  RX-3341 is being developed by Rib-X Pharmaceuticals, Inc. as an antibiotic (a substance which acts to stop/weaken the growth of bacteria that cause infections in the body). It is specifically intended for the treatment of a variety of infections including complicated skin and skin structure infections, complicated abdominal infections and pneumonia. RX-3341 has been tested in over 1000 people with both the oral and intravenous (into a vein) forms of the drug. This intravenous form of the study drug is to be tested in this clinical study. The purpose of the study is to look at how radiolabelled RX-3341 is taken up, broken down and removed by the body, when given as an injection into a vein. Blood, urine and faeces samples will be taken at specific times throughout the study to look at concentrations of the drug in the body. The study will also provide additional safety information on how the body responds to RX-3341. This will be done by collecting laboratory test results, including the results of multiple blood tests, electrocardiograms (ECGs, a measurement of activity of the heart), checking of heart rate, body temperature and blood pressure and by recording any side effects that may occur throughout the study.

• REC name

  Scotland A REC

• REC reference

  11/IE/0049

• Date of REC Opinion

  21 Apr 2011

• REC opinion

  Further Information Favourable Opinion