(14C)-S 42909 Excretion Balance Study in Healthy Male Subjects

• Research type

  Research Study

• Full title

  Excretion balance, pharmacokinetics, and metabolism of S 42909 after single oral dose administration of [14C]-S 42909 in healthy male subjects.

• IRAS ID

  73815

• Contact name

  Ashley Brooks

• Sponsor organisation

  International Centre for Therapeutic Research (UK)

• Eudract number

  2010-023329-39

• Research summary

  S 42909 is a drug being developed for the treatment of leg ulcers caused by venous disease. It is hoped that this drug will stop or slow down a number of processes that lead to leg ulcer formation. The company developing this drug and funding this Study, is known as the ??Sponsor?, and is a French pharmaceutical company called the Institut de Recherches Internationales Servier (Servier). The study is a single centre, open-label and a single oral dose study in healthy male subjects. Five subjects are to be included in this study. The study duration is expected to be up to 7 weeks. The study consists of a single study drug administration in the morning on Day 1 followed by an in-patient period of 7 days (Day 1 to Day 8) to closely monitor subject??s safety and radioactivity levels recovered. An additional in-patient stay of up to 4 days is planned in case the criteria for discharge are not fulfilled at Day 8. Discharge criteria must be assessed every day during the additional in-patient period. If the discharge criteria are still not fulfilled at Day 12, out-patient visits may be required on Day 15, Day 22 or Day 29 to end of the study. Radioactivity counts are checked on a daily basis on blood, plasma, urine and faeces samples. The criteria for discharge include:?½ Cumulative recovery of total radioactivity over 90% and/or, ?½ Level of radioactivity less than 1% in urine and faeces samples combined recovered in two consecutive days. Oral capsules of S 42909 in Gelucire 44/14 are administered on Day 1 as a single total dose of 210 mg containing a maximum total radioactivity of 68.9 æCi (2.53 MBq) from [14C]-S 42909.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0044

• Date of REC Opinion

  11 Apr 2011

• REC opinion

  Further Information Favourable Opinion