SSP-1009G Platelet study

• Research type

  Research Study

• Full title

  A Phase 1, Single-centre, Open-label, 2-cohort Study to Investigate the Effect of Different Dose Regimens of SSP-1009G on Platelet Response in Healthy Subjects

• IRAS ID

  86628

• Contact name

  Ashley Brooks

• Sponsor organisation

  Shire

• Eudract number

  2011-002620-40

• Research summary

  Patients with kidney failure usually require dialysis of their bloodstream to remove waste products or toxic substances that can be life-threatening. This procedure is typically done 3 times per week and requires access to the bloodstream. Failure of this procedure is usually due to development of blood clots and therefore this can lead to deterioration of the condition and even death of these patients. SSP-1009G (??Study drug?) is an investigational drug which is being developed by Shire as a potential treatment to prevent the formation of blood clots associated with dialysis of the bloodstream in patients with kidney failure. This Study drug works by lowering the number of platelets (cells that promote blood clotting) in the blood. Up to 40 healthy volunteers will be participating in this study. The study has been designed to compare the increasing dose and fixed-dose regimens of SSP-1009G in healthy subjects. There are 2 planned cohorts (groups), with 20 subjects in each cohort. Subjects in each cohort will receive the Study drug in different dose regimen. Dosing with the study drug will continue for 42 days in both cohorts. Subjects will also receive a total of 3 doses of Aspirin in this study.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0139

• Date of REC Opinion

  1 Sep 2011

• REC opinion

  Further Information Favourable Opinion