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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lu AG09222; Drug: Placebo

• Registration Number: NCT04976309
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2021-07-15
• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-26
• Primary Completion: 2021-09-19
• Study Completion: 2021-12-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lu AG09222 + VIP and PACAP	Lu AG09222	Lu AG09222, single dose intravenous infusion over 30 minutes
Placebo + saline	Placebo	Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
Placebo + VIP and PACAP	Placebo	Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Danish Headache Center Rigshospitalet Glostrup; 🇩🇰 Glostrup, Denmark