Clinical Trial: Study to Determine How BCX4161 is Metabolized and Eliminated by the Body

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

Official Title: A Phase 1 Study to Evaluate the Absorption, Metabolism and Excretion of BCX4161 Following Administration of a Single, Oral Dose of [14C]-Radiolabelled BCX4161 to Healthy Male Subjects

Brief Summary: The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made by the body, the chemical composition of these metabolites and their profile over time in blood and urine will be determined.

Detailed Summary:
Sponsor: BioCryst Pharmaceuticals

Current Primary Outcome: Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces [ Time Frame: Determined from samples drawn up to 14 days post-dose ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine [ Time Frame: Determined from samples drawn up to 4 days post-dose ]
  • Plasma pharmacokinetics (Cmax, Tmax, Tlag, AUC(0-last), AUC(0-inf), CL/F, Vz/F, AUC%extrapolated,t1/2, as applicable for each analyte) of total radioactivity, BCX4161, [14C] BCX4161 and major metabolites of [14C] BCX4161 [ Time Frame: Data generated from samples drawn up to 7 days post-dose ]
  • Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161 [ Time Frame: Data generated from samples drawn up to 7 days post-dose ]
  • Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations [ Time Frame: Over the duration of the study, approximately 6 weeks from screening through follow-up ]


Original Secondary Outcome: Same as current

Information By: BioCryst Pharmaceuticals

Dates:
Date Received: August 14, 2014
Date Started: August 2014
Date Completion:
Last Updated: October 27, 2014
Last Verified: October 2014