Healthy Clinical Trial
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
Verified date | January 2022 |
Source | H. Lundbeck A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 10, 2021 |
Est. primary completion date | September 19, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Headache Center Rigshospitalet Glostrup | Glostrup |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from start of infusion in STA diameter to 60 min after start of infusion of PACAP38 | 0 to 60 min after infusion | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 |
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