Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 5, 2024

Primary Completion Date

June 29, 2024

Study Completion Date

July 6, 2024

Conditions
Pharmacodynamic
Interventions
DRUG

Vamorolone

vamorolone 20 mg/kg single dose on Day 2

DRUG

Eplerenone

Eplerenone 200 mg single dose on Day 2

DRUG

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."

Trial Locations (1)

89231

Nuvisan GmbH, Neu-Ulm

Sponsors
All Listed Sponsors
lead

Santhera Pharmaceuticals

INDUSTRY

NCT06649409 - Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects | Biotech Hunter | Biotech Hunter