SAP Depleter Dose Assessment Study in Patients
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.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|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 Systemic Amyloidosis|
- Blood concentrations of SAP [ Time Frame: 19 weeks ] [ Designated as safety issue: Yes ]comparison of predicted vs observed
- Plasma concentrations of GSK2315698 [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]changes in plasma concentrations of GSK2315698 over time
- safety and tolerability of GSK2315698 [ Time Frame: 19 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]evaluate effect of GSK2315698 on SAP levels in the blood
|Study Start Date:||October 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Intravenous infusion for approximately 48 hours followed by subcutaneous injection
Intravenous infusion for approximately 48hours followed by subcutaneous injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406314
|GSK Investigational Site|
|Cambridge, United Kingdom, CB2 2GG|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|