NCT01406314

SAP Depleter Dose Assessment Study in Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Amyloidosis

Interventions

Type	Name	Description
DRUG	GSK2315698	Intravenous infusion for approximately 48hours followed by subcutaneous injection

Timeline

• Start date: 2011-10-13
• Primary completion: 2012-11-14
• Completion: 2012-11-14
• First posted: 2011-08-01
• Last updated: 2017-06-09

Locations

1 site across 1 country: United Kingdom