Clinical trial NCT04976309: A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 0 to 120 min after infusion
Secondary outcomes:
measure: Change from start of infusion in STA diameter to 60 min after start of infusion of PACAP38
timeFrame: 0 to 60 min after infusion
measure: Maximum change from start of infusion in STA diameter between 0 and 120 min after start of infusion of PACAP38
timeFrame: 0 and 120 min after infusion
measure: AUC in change from start of infusion in facial blood flow from 0 to 120 min after start of infusion of PACAP38
timeFrame: 0 to 120 min after infusion
measure: AUC in change from start of infusion in heart rate from 0 to 120 min after start of infusion of PACAP38
timeFrame: 0 to 120 min after infusion
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center Rigshospitalet Glostrup
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: