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

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ClinicalTrials.gov Identifier: NCT04976309
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lu AG09222 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 15, 2021
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : December 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Placebo + saline
Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
Drug: Placebo
Single dose

Experimental: Placebo + VIP and PACAP
Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
Drug: Placebo
Single dose

Experimental: Lu AG09222 + VIP and PACAP
Lu AG09222, single dose intravenous infusion over 30 minutes
Drug: Lu AG09222
Single dose




Primary Outcome Measures :
  1. 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 [ Time Frame: 0 to 120 min after infusion ]

Secondary Outcome Measures :
  1. Change from start of infusion in STA diameter to 60 min after start of infusion of PACAP38 [ Time Frame: 0 to 60 min after infusion ]
  2. Maximum change from start of infusion in STA diameter between 0 and 120 min after start of infusion of PACAP38 [ Time Frame: 0 and 120 min after infusion ]
  3. AUC in change from start of infusion in facial blood flow from 0 to 120 min after start of infusion of PACAP38 [ Time Frame: 0 to 120 min after infusion ]
  4. AUC in change from start of infusion in heart rate from 0 to 120 min after start of infusion of PACAP38 [ Time Frame: 0 to 120 min after infusion ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04976309


Contacts
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Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

Locations
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Denmark
Danish Headache Center Rigshospitalet Glostrup Recruiting
Glostrup, Denmark, 2600
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04976309    
Other Study ID Numbers: 19734A
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations