Inhibition of Sterile Inflammation by Digoxin

• Status: Recruiting
• Trial end date: 2023-07-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Treatments: Digoxin

Criteria

Inclusion Criteria

1. Age >18 y ≤ 70 years

2. subjects with normal serum creatinine, normal EKG and currently not taking any medication.

Exclusion criteria

1. Autoimmune liver disease (ANA > 1/320)

2. Chronic viral hepatitis

3. Hepatocellular carcinoma

4. Complete portal vein thrombosis

5. Extrahepatic terminal disease

6. Pregnancy

7. Treatment with prednisolone or pentoxifyllin for more than 3 days prior to inclusion/start date

8. Active alcohol abuse (>50 g/day for men and >40 g/day for women) in the last 3 months

9. AST > ALT and total bilirubin > 3 mg/dl in the past 3 months

10. Liver biopsy and/or clinical picture consistent with alcoholic hepatitis

11. Lack of signed informed consent.

12. Known hypersensitivity to digoxin or other forms of digitalis, ventricular fibrillation.

13. Any significant medical conditions, any electrolyte abnormalities, over the counter medications, natural products and prescription drugs.