Back to resultsA Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Lu AG09222
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility 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.
Sites / Locations
- Danish Headache Center Rigshospitalet Glostrup
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Placebo + saline
Placebo + VIP and PACAP
Lu AG09222 + VIP and PACAP
Arm Description
Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
Lu AG09222, single dose intravenous infusion over 30 minutes
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from start of infusion in STA diameter to 60 min after start of infusion of PACAP38
Maximum change from start of infusion in STA diameter between 0 and 120 min after start of infusion of PACAP38
AUC in change from start of infusion in facial blood flow from 0 to 120 min after start of infusion of PACAP38
AUC in change from start of infusion in heart rate from 0 to 120 min after start of infusion of PACAP38
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04976309
Brief Title
A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
September 19, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo + saline
Arm Type
Experimental
Arm Description
Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
Arm Title
Placebo + VIP and PACAP
Arm Type
Experimental
Arm Description
Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
Arm Title
Lu AG09222 + VIP and PACAP
Arm Type
Experimental
Arm Description
Lu AG09222, single dose intravenous infusion over 30 minutes
Intervention Type
Drug
Intervention Name(s)
Lu AG09222
Intervention Description
Single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Danish Headache Center Rigshospitalet Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects
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