30
Participants
Start Date
June 5, 2024
Primary Completion Date
June 29, 2024
Study Completion Date
July 6, 2024
Vamorolone
vamorolone 20 mg/kg single dose on Day 2
Eplerenone
Eplerenone 200 mg single dose on Day 2
Fludrocortisone
"Fludrocortisone challenge on Days 1 to 3 (for all subjects):~Day 1:~-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm~Day 2:~* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.~* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.~* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.~Day 3:~-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm."
Nuvisan GmbH, Neu-Ulm
Lead Sponsor
Santhera Pharmaceuticals
INDUSTRY