Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649409
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PK of a single dose of vamorolone and a single dose of eplerenone combined with fludrocortisone challenge will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None