Safety and PK of S 42909 after single and repeated doses & food effect

• Research type

  Research Study

• Full title

  Safety and pharmacokinetics of S 42909 after single and repeated ascending oral doses with food effect assessment in young healthy male participants.

• IRAS ID

  114755

• Contact name

  Simon L Singer

• Sponsor organisation

  Institut de Recherches Internationales Servier

• Eudract number

  2012-003193-69

• Research summary

  This study to investigate a potential new treatment for conditions associated with vein problems. The research will be carried out at ICON Development Solutions Clinical Research Unit in Manchester. Up to 50 male, Caucasian volunteers aged 18 - 55 will participate in the trial. Volunteers will either receive a dose of S 42909 or a dummy drug (placebo). Neither the study team nor the participants will know which treatment they receive. As this is a study in healthy volunteers, no direct health benefits are expected from participation in the trial.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0691

• Date of REC Opinion

  19 Nov 2012

• REC opinion

  Further Information Favourable Opinion