Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04976309
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2021-07-19
Brief Title:
A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects
Sponsor:
H Lundbeck AS
Organization:
H Lundbeck AS
Study Overview
Official Title:
Interventional Randomized Double-blind Parallel-group Placebo-controlled Study Investigating the Effect of Lu AG09222 on PACAP38- and VIP-induced Vasodilation Heart Rate Increase and Headache in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-01
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 evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model
Detailed Description:
This study will investigate the effect of preventive treatment with Lu AG09222 on vasodilation heart rate increase and headache induced by PACAP and VIP
Subjects will be randomised to three arms placebo saline placebo VIP and PACAP and Lu AG09222 VIP and PACAP Subjects who complete the study will attend a safety follow-up visit at 10 to 12 weeks after administration of investigational medicinal product
Subjects will be randomised to three arms placebo saline placebo VIP and PACAP and Lu AG09222 VIP and PACAP Subjects who complete the study will attend a safety follow-up visit at 10 to 12 weeks after administration of investigational medicinal product
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