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NCT03163173 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects
A Phase 1 study, sponsored by Galera Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03163173: Completed Phase 1 study, sponsored by Galera Therapeutics.
NCT03163173 is a Phase 1 study that has completed, run by Galera Therapeutics. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03163173, a Phase 1 study, has completed, sponsored by Galera Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
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.
Primary Outcome
Total radioactivity found in biological specimens
Interventions
- DRUG GC4419
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-08-14 |
| Est. Completion | 2017-10-13 |
| Phase | Phase 1 |
What the finished NCT03163173 record still lists
NCT03163173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which GC4419 is the first listed.
NCT03163173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03163173 about?
NCT03163173 is a clinical study titled "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 d...
What is the current status of trial NCT03163173?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-08-14. Estimated completion is 2017-10-13.
What interventions are being tested in trial NCT03163173?
The interventions under investigation include: GC4419 (DRUG).
Who is sponsoring clinical trial NCT03163173?
This trial is sponsored by Galera Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03163173's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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