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

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT04976309
Collaborator
(none)
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Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual 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 :
Jul 15, 2021
Actual Primary Completion Date :
Sep 19, 2021
Actual Study Completion Date :
Dec 10, 2021

Arms and Interventions

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

Outcome Measures

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 [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 [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 [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 [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 [0 to 120 min after infusion]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Danish Headache Center Rigshospitalet Glostrup Glostrup Denmark 2600

Sponsors and Collaborators

  • H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT04976309
Other Study ID Numbers:
  • 19734A
First Posted:
Jul 26, 2021
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022