Trials / Completed
CompletedNCT04976309
A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lu AG09222 | Single dose |
| DRUG | Placebo | Single dose |
Timeline
- Start date
- 2021-07-15
- Primary completion
- 2021-09-19
- Completion
- 2021-12-10
- First posted
- 2021-07-26
- Last updated
- 2022-01-19
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04976309. Inclusion in this directory is not an endorsement.