Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + saline | Experimental | Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes |
|
| Placebo + VIP and PACAP | Experimental | Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes |
|
| Lu AG09222 + VIP and PACAP | Experimental | Lu AG09222, single dose intravenous infusion over 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG09222 | Drug | Single dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of change from start of infusion in superficial temporal artery (STA) diameter from 0 to 120 min after start of infusion of PACAP38 | 0 to 120 min after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change from start of infusion in STA diameter to 60 min after start of infusion of PACAP38 | 0 to 60 min after infusion | |
| Maximum change from start of infusion in STA diameter between 0 and 120 min after start of infusion of PACAP38 | 0 and 120 min after infusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center Rigshospitalet Glostrup | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37231350 | Derived | Rasmussen NB, Deligianni C, Christensen CE, Karlsson WK, Al-Khazali HM, Van de Casteele T, Granhall C, Amin FM, Ashina M. The effect of Lu AG09222 on PACAP38- and VIP-induced vasodilation, heart rate increase, and headache in healthy subjects: an interventional, randomized, double-blind, parallel-group, placebo-controlled study. J Headache Pain. 2023 May 25;24(1):60. doi: 10.1186/s10194-023-01599-w. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Single dose |
|
| AUC in change from start of infusion in facial blood flow from 0 to 120 min after start of infusion of PACAP38 | 0 to 120 min after infusion |
| AUC in change from start of infusion in heart rate from 0 to 120 min after start of infusion of PACAP38 | 0 to 120 min after infusion |