Phase 1
N=42
Inhibition of Sterile Inflammation by Digoxin
Inflammatory Response
Bottom Line
View on ClinicalTrials.gov: NCT03559868 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Digoxin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production |
— | — |
| PRIMARY Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production |
— | — |
| PRIMARY Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production |
— | — |
| PRIMARY Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production |
— | — |
| SECONDARY Investigation of How Human Peripheral Blood Immune Cells Change Their Inflammatory Responses After Exposure to Digoxin in Vitro |
697; 1351; 5790; 1205; 12180; 22328 | <0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Age >18 y ≤ 70 years
- subjects with normal serum creatinine, normal EKG and currently not taking any medication.
Exclusion criteria
- Autoimmune liver disease (ANA > 1/320)
- Chronic viral hepatitis
- Hepatocellular carcinoma
- Complete portal vein thrombosis
- Extrahepatic terminal disease
- Pregnancy
- Treatment with prednisolone or pentoxifyllin for more than 3 days prior to inclusion/start date
- Active alcohol abuse (>50 g/day for men and >40 g/day for women) in the last 3 months
- AST > ALT and total bilirubin > 3 mg/dl in the past 3 months
- Liver biopsy and/or clinical picture consistent with alcoholic hepatitis
- Lack of signed informed consent.
- Known hypersensitivity to digoxin or other forms of digitalis, ventricular fibrillation.
- Any significant medical conditions, any electrolyte abnormalities, over the counter medications, natural products and prescription drugs.
Data sourced from ClinicalTrials.gov (NCT03559868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.