NCT03559868

Inhibition of Sterile Inflammation by Digoxin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

To investigate the effect of orally administered digoxin on innate immune inflammatory responses in the peripheral blood of healthy subjects. We hypothesize the reduction in innate immune inflammatory responses will be expected in the peripheral blood with the effect of oral digoxin. To investigation how human peripheral blood immune cells change their inflammatory responses after exposure to digoxin in vitro.

Conditions

• Inflammatory Response

Interventions

Type	Name	Description
DRUG	Digoxin	Participants will receive 3 mcg/Kg/day doses of oral digoxin
OTHER	Placebo	Oral placebo
DRUG	Digoxin	Participants will receive 0.15 mcg/Kg/day doses of oral digoxin

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2018-06-18
• Last updated: 2024-07-12
• Results posted: 2024-07-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study