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Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

NCT06649409 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-11

Study results available
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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.

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.

Sponsors & Collaborators

  • Santhera Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Steffen Haffner, MD · Nuvisan GmbH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2024-06-29
Completion
2024-07-06

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649409 on ClinicalTrials.gov