Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-29 @ 4:10 AM
Study NCT ID:
NCT05201092
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2022-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Investigating Lu AG06466 in Healthy Men
Sponsor:
H. Lundbeck A/S
Organization:
Study Overview
Official Title:
Interventional, Open-Label, Single-Dose Study Investigating the Absorption, Metabolism and Excretion (AME) of Lu AG06466 Following Oral Dosing of 14C-Lu AG06466 to Healthy Men
Status:
COMPLETED
Status Verified Date:
2022-03
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:
None
Brief Summary:
The purpose of this study is to investigate how the drug Lu AG06466 is absorbed, metabolized, and excreted from the body, for example, what the body does to the drug after swallowing a single dose.
Detailed Description:
Researchers will measure the levels of the drug and its breakdown product in each participants blood for up to 5 days after dosing. Radioactivity in urine and feces will be measured for up to 3.5 weeks after dosing.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-002048-54 | EUDRACT_NUMBER | None | View |