Ignite Creation Date:
2024-07-17 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471829
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Brief Title:
A Trial of Lu AG13909 in Adult Participants With Cushings Disease
Sponsor:
H Lundbeck AS
Organization:
H Lundbeck AS
Study Overview
Official Title:
A Phase II Multi-site Open-label Dose-titration Trial to Investigate the Safety Tolerability Pharmacokinetics and Efficacy of Lu AG13909 in Adults With Cushings Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BalanCeD
Brief Summary:
This trial will evaluate the effects of Lu AG13909 in adult participants with Cushings disease CD Cushings disease is a rare and serious disorder where the body makes too much of a hormone called cortisol The main goals of this trial are to learn about
1 the effect of Lu AG13909 on cortisol levels
2 the safety and tolerability of Lu AG13909
3 the pharmacokinetic parameters of Lu AG13909 how the drug is absorbed distributed and processed by the body
1 the effect of Lu AG13909 on cortisol levels
2 the safety and tolerability of Lu AG13909
3 the pharmacokinetic parameters of Lu AG13909 how the drug is absorbed distributed and processed by the body
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504733-53-00 | OTHER | None | None |