(duplicate) Badimon Chamber Study

• Research type

  Research Study

• Full title

  An open label, phase 1, single sequence crossover study to investigate the relationship between platelet count and Ex Vivo thrombus quantity and characteristics in healthy adult male volunteers following oral administration of SSP-1009B with and without Aspirin

• IRAS ID

  49846

• Contact name

  Azfar Zaman

• Sponsor organisation

  Shire Pharmaceutical Development

• Eudract number

  2010-018445-60

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study will investigate the relationship between platelet count, the test drug (SSP-1009B), simultaneous use of the test drug and aspirin, and thrombus (blood clot) formation in healthy volunteers. The results of this study will be used to identify a target range of platelet counts for evaluation in future studies of SSP-1009B. Because SSP-1009B reduces platelet count, Shire expects to demonstrate that SSP-1009B can prevent occlusive complications (blod clots) to occur at the site where vascular access is created for End Stage Renal Disease (ESRD) patients undergoing regular hemodyalisis. The subjects in this study are healthy volunteers and will be tested and monitored at the Clinical Research Facilityat the Royal Victoria Infirmary, Newcastle upon Tyne. Upon qualifying for the study, the subjects will be treated for 14 days with the SSP-1009B, and then again for 14 days with SSP-1009B and aspirin. Six weeks will separate the 2 treatment phases. Each evaluation of the ex vivo Badimon perfusion chamber requires approximately 60mL of blood (WǾhlander et al. 2006), which limits the number of evaluations that can be performed over a 21-day period. Therefore, in order to evaluate the effect of platelet count on thrombus formation at various times and platelet counts, subjects will be assigned to one of two observations schedules. Subjects in Panel A will be evaluated on Day 1, 7, 14, and 21 of each treatment period, and subjects in Panel B will be evaluated on Days 1, 4, 10, and 18 of each treatment period.

• REC name

  HSC REC A

• REC reference

  10/NIR01/10

• Date of REC Opinion

  8 Apr 2010

• REC opinion

  Favourable Opinion