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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 is a Early Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 11 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04814602
The ClinicalTrials.gov registry entry for NCT04814602 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Proglumide is the first listed.
NCT04814602 reports 0 study locations.
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.
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