NCT03886922

The Hemodynamics Effect of Glibenclamide on Levcromakalim Assessed by High Resolution Magnetic Resonance Angiography (MRA) Technique in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers

The Hemodynamics Effect of Levcromakalim After Glibenclamide Administration Assessed by High Resolution MRA Technique in a Randomized, Double-blind, Cross-over and Placebo-controlled Study With Healthy Volunteers.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To investigate the effect of levcromakalim/placebo infusion on cranial arteries after glibenclamide administration.

Detailed description

15 healthy participants will randomly be allocated to receive levcromakalim or placebo on to different days before and after oral glibenclamide administration. The aim of the study is to investigate the effect of levcromakalim/placebo infusion on cranial arteries before and after glibenclamide administration. Repeated magnetic resonance angiography (MRA) measurements covering the middle meningeal artery (MMA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide administration and levcromakalim/placebo infusion.

Conditions

• Hemodynamics of Cranial Arteries
• Headache
• Cerebral Blood Flow

Interventions

Type	Name	Description
DRUG	Levcromakalim	Intravenous infusion of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cranial arteries in healthy volunteers after glibenclamide administration.
DRUG	Saline	Intravenous infusion of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cranial arteries in healthy volunteers after glibenclamide administration.

Timeline

• Start date: 2019-04-01
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2019-03-22
• Last updated: 2022-07-07

Locations

2 sites across 1 country: Denmark