NCT06387862

Pharmacokinetics of Inhaled Levosimendan

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan.

Conditions

• Left Ventricular Dysfunction

Interventions

Type	Name	Description
DRUG	Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled	Each patient will receive 12µg/kg of levosimendan by inhalation over 10 min. During 10h following inhaled dose, plasma concentrations will be measured.
DRUG	Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous	Each patient will receive 12µg/kg of levosimendan by intravenous (IV) administration over 10 min and at the same timepoints plasma samples will be measured

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-11-01
• Completion: 2025-01-01
• First posted: 2024-04-29
• Last updated: 2024-05-20

Locations

1 site across 1 country: Belgium