NCT06649409

Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

An Open-label, Randomized, 3-arm, Parallel-group, Positive- and Negative-arm Controlled Study to Evaluate the Mineralocorticoid Receptor Antagonism Effect of Vamorolone in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate if the trial drug vamorolone is able to block a specific receptor in the body called mineralocorticoid receptor. This receptor helps to regulate salt and water balance.

Detailed description

The purpose of this study is to investigate the antagonistic effect of vamorolone on the mineralocorticoid receptor following mineralocorticoid challenge by fludrocortisone, compared to eplerenone as a positive control, and to a negative control with no study treatment. Furthermore, the safety and tolerability of vamorolone combined with fludrocortisone challenge will be assessed, and the Pharmacokinetic (PK) of a single dose of vamorolone and a single dose of eplerenone, combined with fludrocortisone challenge, will be evaluated.

Conditions

• Pharmacodynamic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-05
• Primary completion: 2024-06-29
• Completion: 2024-07-06
• First posted: 2024-10-18
• Last updated: 2025-09-11
• Results posted: 2025-09-11

Locations

1 site across 1 country: Germany