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NCT03559868 · ClinicalTrials.gov registry record · Phase 1
Inhibition of Sterile Inflammation by Digoxin
A Phase 1 study of Inflammatory Response, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT03559868: Completed Phase 1 study of Inflammatory Response, sponsored by Yale University.
NCT03559868 is a Phase 1 study of Inflammatory Response that has completed, run by Yale University. The registered enrollment target is 45 participants, below the 175-participant average among 16 other Inflammatory Response trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03559868, a Phase 1 study of Inflammatory Response, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
To investigate the effect of digoxin on pyruvate kinase isoform 2 (PKM2) binding to pro-inflammatory loci and innate immune inflammatory responses in the peripheral blood in healthy subjects.
Primary Outcome
Investigators will be take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Digoxin
Study Locations (1)
Connecticut
- Yale Centre of Clinical Investigation - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2023-05-05 |
| Phase | Phase 1 |
What the finished NCT03559868 record still lists
NCT03559868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 175-participant average among 16 other Inflammatory Response trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Inflammatory Response appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03559868 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT03559868 about?
NCT03559868 is a clinical study titled "Inhibition of Sterile Inflammation by Digoxin". To investigate the effect of digoxin on pyruvate kinase isoform 2 (PKM2) binding to pro-inflammatory loci and innate immune inflammatory responses in the peripheral blood in healthy subjects.
What is the current status of trial NCT03559868?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2021-03-01. Estimated completion is 2023-05-05.
What conditions does trial NCT03559868 study?
This clinical trial studies the following conditions: Inflammatory Response.
What interventions are being tested in trial NCT03559868?
The interventions under investigation include: Placebo (OTHER), Digoxin (DRUG).
Who is sponsoring clinical trial NCT03559868?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03559868 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03559868's enrollment target sits among peer trials
45 11th of 16 higher than 6 of 16 other Inflammatory Response trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Response 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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