Healthy
Conditions
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.
Interventions
DRUGLu AG09222
Single dose
DRUGPlacebo
Single dose
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject has a body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, and a body weight ≥ 45 and ≤ 95 kg at the screening visit. * The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests at screening.
Exclusion criteria
* The subject fulfils the diagnostic criteria for a primary headache disorder, or has a first degree relative with a primary headache disorder, according to the International Headache Society (IHS) International Classification of Headache Disorders 3rd edition (ICHD-3), except tension-type headache. * The subject has or has had tension-type headache more than once per month on average during the 6 months prior to the screening visit. Other inclusion and
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
Denmark
Outcome results
None listed