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NCT04814602 · ClinicalTrials.gov registry record · Early Phase 1
Single-dose PK Assessment of Oral Proglumide in Those With Hepatic Impairment
A Early Phase 1 study, sponsored by Georgetown University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT04814602: Completed Early Phase 1 study, sponsored by Georgetown University.
NCT04814602 is a Early Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 11 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04814602, a Early Phase 1 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Proglumide is an oral cholecystokinin (CCK) receptor antagonist that has been shown in non-clinical studies to reverse hepatic fibrosis and decrease the incidence of hepatocellular carcinoma (HCC). Because of these potential beneficial properties, proglumide may be useful in decreasing the fibrosis and risk for HCC in those with cirrhosis. Although proglumide is safe in those with normal hepatic function, the pharmacokinetics have not been established in those that are hepatic impaired. The purpose of this study is to analyze proglumide blood levels and excretion in subjects with cirrhosis compared to health controls.
Primary Outcome
Proglumide levels in ng/ml in cirrhosis subjects compared to healthy controls
Interventions
- DRUG Proglumide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-03-30 |
| Est. Completion | 2022-02-20 |
| Phase | Early Phase 1 |
What the finished NCT04814602 record still lists
NCT04814602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Proglumide is the first listed.
NCT04814602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04814602 about?
NCT04814602 is a clinical study titled "Single-dose PK Assessment of Oral Proglumide in Those With Hepatic Impairment". Proglumide is an oral cholecystokinin (CCK) receptor antagonist that has been shown in non-clinical studies to reverse hepatic fibrosis and decrease the incidence of hepatocellular carcinoma (HCC). Because of these potential beneficial properties, proglumide may be useful in decreasing the fibrosis ...
What is the current status of trial NCT04814602?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2021-03-30. Estimated completion is 2022-02-20.
What interventions are being tested in trial NCT04814602?
The interventions under investigation include: Proglumide (DRUG).
Who is sponsoring clinical trial NCT04814602?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04814602's enrollment target sits among peer trials
11 1600th of 2000 higher than 373 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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