SAP depleter study in patients with systemic amyloidosis

• Research type

  Research Study

• Full title

  A Phase 1, open label, dose characteristic study to investigate the pharmacokinetics, pharmacodynamics, safety, and tolerability of intravenous and subcutaneous doses of GSK2315698A in patients with systemic amyloidosis

• IRAS ID

  75734

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2010 020736-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Systemic amyloidosis is a disease caused by the progressive build up of amyloid in various body parts causing organ failure and death. Amyloidosis is complex but always includes a protein called serum amyloid P. There are currently no effective medications that can clear amyloid deposits in this condition. GSK is developing a new drug (GSK2315698) that binds serum amyloid P in the bloodstream and which may reduce the formation of amyloid deposits. This study will assess the safety, tolerability, metabolism and effects of GSK2315698 in patients with systemic amyloidosis.Approximately 15 to 30 patients will be recruited for this study. Each subject will be asked to attend one screening, 2 treatment sessions, 3 outpatient visits and 1 follow-up visit. The total duration of this study is up to 19 weeks for each patient. Each treatment visit will last 3 or 4 days with overnight stays atthe clinical unit. During treatment session 1 each volunteer will be given a single intravenous (into a vein) dose of GSK2315698 over 48 hours followed by a single subcutaneous (under the skin)dose at 48 hours. Each patient will then attend another treatment session when a 48 hour intravenous infusion of GSK2315698 will be given followed by up to 3 separate subcutaneous dose(s)over 24 hours. The doses to be given will be adapted based on information collected in the study and from an ongoing study involving healthy volunteers. The starting dose will be 520mg of GSK2315698 over 48 hours. The safety and tolerability of GSK2315698 will be monitored closely. The blood levels of serum amyloid P and other biomarkers will be checked.The amount of GSK2315698 and its metabolites in blood, bile and urine will also be assessed. After the end of the treatment visits, patients will attend the clinic for a final follow-up visit.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  11/EE/0178

• Date of REC Opinion

  14 Jun 2011

• REC opinion

  Further Information Favourable Opinion