Healthy Clinical Trial
Official title:
A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects
GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer
patients who receive radiation and chemotherapy.
In this study, GC4419 will be mixed with a small amount of radioactive material in order to
find out how much study drug is in the blood and to see how the drug is processed and
eliminated from the body. The safety and how subjects tolerate the study drug will also be
studied.
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.
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