NCT03163173

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Galera Therapeutics, Inc. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers
• Healthy

Interventions

Type	Name	Description
DRUG	GC4419	30 mg (\~100 μCi) dose of \[14C\]GC4419

Timeline

• Start date: 2017-08-14
• Primary completion: 2017-10-13
• Completion: 2017-10-13
• First posted: 2017-05-22
• Last updated: 2017-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study