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

NCT03163173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-11-17

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers
  • Healthy

Interventions

DRUG

GC4419

30 mg (\~100 μCi) dose of \[14C\]GC4419

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Galera Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jon T Holmlund, MD · Galera Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-14
Primary Completion
2017-10-13
Completion
2017-10-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163173 on ClinicalTrials.gov