Clinical Trial: GSK2251052 Mass Balance in Healthy Adult Subjects

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

Official Title: An Open Label, Non-Randomized, Single Dose, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2251052 Administered as a Single Intravenous Dose to Healthy Adult

Brief Summary: Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose of 14C-GSK2251052 under fasted conditions. Blood, urine and fecal samples will be collected for a minimum of 14 days following study drug administration. Safety and tolerability will be monitored throughout the study. A follow-up visit will occur 7-14 days after study drug administration.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Evaluate pharmacokinetic parameters for GSK2251052 and radiolabeled compound following intravenous dose [ Time Frame: Up to 14 days ]
  • Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time [ Time Frame: Up to 14 days ]
  • Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments [ Time Frame: Up to 14 days ]
  • Maximum observed concentration [ Time Frame: Up to 14 days ]
  • Time of occurrence of maximum observed concentration [ Time Frame: Up to 14 days ]
  • Terminal phase half-life [ Time Frame: Up tp 14 days ]
  • Systemic clearance of parent drug [ Time Frame: Up to 14 days ]
  • Volume of distribution [ Time Frame: Up to 14 days ]
  • Percent recovery of total radiocarbon in urine and feces [ Time Frame: Up to 14 days ]
  • Urine, fecal recovery and total recovery of radioactivity (as a percentage of total radioactive dose in each interval and cumulative) [ Time Frame: Up to 14 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse events, vital signs, electrocardiogram and clinical laboratory assessments. [ Time Frame: Up to 14 days ]
  • Collection of samples for characterization and quantification, or estimation, of GSK2251052-related metabolites in plasma, urine and fecal homogenates to be conducted under a separate protocol. [ Time Frame: Up to 14 days ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: November 17, 2011
Date Started: April 2011
Date Completion:
Last Updated: March 8, 2012
Last Verified: December 2011