A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04976309
• Other study ID #: 19734A
• Status: Completed
• Phase: Phase 1
• Start date: July 15, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: January 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Headache
• Healthy

Intervention

Drug:
• Lu AG09222
Single dose
• Placebo
Single dose

Locations

Country	Name	City	State
Denmark	Danish Headache Center Rigshospitalet Glostrup	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Denmark, 

Outcome

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