Clinical Trial: SAP Depleter Dose Escalation Study in Healthy Volunteers

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

Official Title: A Phase 1 Dose Escalation Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Intravenous Doses of GSK2315698A in Healthy Volunteers

Brief Summary: The purpose of this study is to provide safety information and to define the optimal induction and short term maintenance regimen for GSK2315698 to deplete circulating SAP in healthy volunteers prior to assessing in patients

Detailed Summary: This single centre, open label, dose escalation study is designed to assess safety (including adverse events, vital signs, ECGs, and clinical laboratory tests), and pharmacokinetic /pharmacodynamic parameters in healthy volunteers. Subjects will attend for 3 sessions: session 1 is a single intravenous (IV) infusion over a short time period to confirm the safety of a single dose of GSK2315698 over a wide dose range, sessions 2 and 3 will investigate IV infusion regimens over 24 hours (induction phase followed by maintenance phase). The dosing regimen will be adjusted adaptively to optimise the induction and maintenance phases of the dosing regimen. amyloidosis.
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • An assessment of the safety and tolerability of single intravenous dose of GSK2315698 [ Time Frame: 12 weeks ]
  • To characterize the PK/PD relationship GSK2315698 in order to define an intravenous dosing regimen that provides optimal depletion of blood SAP over a 24 hour period (in healthy volunteers) [ Time Frame: 12 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Measure the pharmacokinetics of IV administration of GSK2315698 [ Time Frame: 12 weeks ]
  • Measure depletion of SAP following IV administration of GSK2315698 [ Time Frame: 12 weeks ]
  • Measure the kinetics of SAP production and SAP degradation in healthy volunteers [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: March 24, 2011
Date Started: January 2011
Date Completion:
Last Updated: July 26, 2011
Last Verified: July 2011