Clinical Trial: SAP Depleter Dose Assessment Study in Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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 S

Brief Summary: This study aims to provide safety information on the ligand, GSK2315698A. The pharmacokinetics and pharmacodynamics of the ligand will be determined together with the differences in routes of dose administration, namely the tolerability between intravenous versus subcutaneous dose administration. The study will be carried out in patients with systemic amyloidosis and the ability of GSK2315698A in depleting levels of serum amyloid protein (SAP) will be measured.

Detailed Summary: This study is an open label, dose characteristic study assessing safety and pharmacokinetic and pharmacodynamic considerations of GSK2315698A. GSK2315698A is a ligand known to bind to serum amyloid protein (SAP), a key component of an anti-SAP approach to the treatment of systemic amyloidosis. Safety assessments will include adverse events, vital signs, ECGs and other relevant clinical laboratory tests. Dose administration routes will also be determined focusing on the tolerability of intravenous dose administration versus subcutaneous. The study aims to recruit up to 30 patients with a medical diagnosis of systemic amyloidosis. Subjects will be asked to attend 2 dosing sessions, each session will involve an intravenous infusion of GSK2315698A over 48 hours followed by a single subcutaneous dose in session 1 and up to 3 subcutaneous doses in session 2 to be administered over a 24 hour period.
Sponsor: GlaxoSmithKline

Current Primary Outcome:

• Blood concentrations of SAP [ Time Frame: 19 weeks ]
  comparison of predicted vs observed
• Plasma concentrations of GSK2315698 [ Time Frame: 19 weeks ]
  changes in plasma concentrations of GSK2315698 over time

Original Primary Outcome: Same as current

Current Secondary Outcome:

• safety and tolerability of GSK2315698 [ Time Frame: 19 weeks ]
  evaluated by adverse event (AE) reporting, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG).
• Change from baseline in blood SAP levels [ Time Frame: 19 weeks ]
  evaluate effect of GSK2315698 on SAP levels in the blood

Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: July 26, 2011
Date Started: October 2011
Date Completion:
Last Updated: December 13, 2012
Last Verified: December 2012