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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lu AG09222; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04976309

19734A

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 3 patient groups

Placebo + saline

Experimental group

Description:

Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes

Treatment:

Drug: Placebo

Placebo + VIP and PACAP

Experimental group

Description:

Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes

Treatment:

Drug: Placebo

Lu AG09222 + VIP and PACAP

Experimental group

Description:

Lu AG09222, single dose intravenous infusion over 30 minutes

Treatment:

Drug: Lu AG09222