A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects


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Primary Outcome Measures:

  • Mass balance of GC4419 [ Time Frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)] ]

    Total radioactivity found in biological specimens

  • Total radioactivity in plasma (AUC0-t) [ Time Frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)] ]

    The area under the concentration time or concentration equivalent time curve, from time 0 to the last observed non-zero concentration (Ct)

  • Major metabolites in biological specimens. [ Time Frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)] ]

    Total concentrations of GC4419 and its metabolites found in biological specimens

  • 14C radioactivity in whole blood [ Time Frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)] ]

    Change over time in percentage of 14C radioactivity in whole blood

  • Total radioactivity in plasma (Cmax) [ Time Frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)] ]

    Maximum observed concentration or concentration equivalent

  • Total radioactivity in plasma (Tmax) [ Time Frame: From dosing until discharge criteria are met [up to a maximum stay of 28 days postdose (Day 29)] ]

    Time to reach Cmax

This is an open-label, single-dose, 1-period study.

On Day 1, a single 30 mg (~100 μCi) dose of [14C]GC4419 will be administered as an IV infusion over 15 minutes. Blood, urine, and fecal samples will be collected to measure total radioactivity (plasma, whole blood, urine, and fecal samples), for GC4419 and its metabolites GC4520 and GC4570 concentrations (plasma, urine, and fecal samples), and for metabolic profiling (plasma, urine, and fecal samples), as total amounts of radioactivity allow, for at least 168 hours postdose (Day 8).

If discharge criteria are not met on Day 8, collection of blood will be collected approximately every 72 hours, and urine and feces collection will continue in 24-hour intervals thereafter (for determination of total radioactivity and metabolic profiling only) until the discharge criteria are met or up to a maximum stay of 28 days (Day 29).

The clinic will attempt to contact all subjects (including subjects who terminate the study early) using their standard procedures approximately 14 days after the last sample collection to determine if any adverse event has occurred since the last sample collection.

Six (6), healthy, adult, non tobacco using, male subjects will be enrolled.