HealthyPhase 1NCT04976309
A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects
A Phase 1 study testing Lu AG09222 in people with Healthy, run by H. Lundbeck A/S at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lu AG09222
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jul 2021to 10 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center Rigshospitalet Glostrup
Glostrup Municipality, 2600
About this study
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
The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model.
Read the 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.
- Conditions
- Healthy
- Being tested
- Lu AG09222, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG09222Drug
Single dose
PlaceboDrug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo + saline | Experimental | Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes Receives: Drug: Placebo |
| Placebo + VIP and PACAP | Experimental | Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes Receives: Drug: Placebo |
| Lu AG09222 + VIP and PACAP | Experimental | Lu AG09222, single dose intravenous infusion over 30 minutes Receives: Drug: Lu AG09222 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 to 120 min after infusion
Secondary outcomes (4)
Change from start of infusion in STA diameter to 60 min after start of infusion of PACAP38
Measured: 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
Measured: 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
Measured: 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
Measured: 0 to 120 min after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start15 Jul 2021
- Primary completion19 Sep 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976309
- Sponsor's protocol ID
- 19734A
- Status last verified
- Jan 2022
- First submitted
- 19 Jul 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rasmussen NB, Deligianni C, Christensen CE, Karlsson WK, Al-Khazali HM, Van de Casteele T, Granhall C, Amin FM, Ashina M. The effect of Lu AG09222 on PACAP38- and VIP-induced vasodilation, heart rate increase, and headache in healthy subjects: an interventional, randomized, double-blind, parallel-group, placebo-controlled study. J Headache Pain. 2023 May 25;24(1):60. doi: 10.1186/s10194-023-01599-w.
PubMed 37231350
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04976309
- Acronym / sponsor ID
- 19734A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 19 Sep 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo + saline | Experimental | Drug: PlaceboPlacebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes |
| Placebo + VIP and PACAP | Experimental | Drug: PlaceboPlacebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes |
| Lu AG09222 + VIP and PACAP | Experimental | Drug: Lu AG09222Lu AG09222, single dose intravenous infusion over 30 minutes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AG09222Single dose | Drug | Lu AG09222 + VIP and PACAP |
| PlaceboSingle dose | Drug | Placebo + VIP and PACAP, Placebo + saline |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Derived from this study: PubMed 37231350Rasmussen NB, Deligianni C, Christensen CE, Karlsson WK, Al-Khazali HM, Van de Casteele T, Granhall C, Amin FM, Ashina M. The effect of Lu AG09222 on PACAP38- and VIP-induced vasodilation, heart rate increase, and headache in healthy subjects: an interventional, randomized, double-blind, parallel-group, placebo-controlled study. J Headache Pain. 2023 May 25;24(1):60. doi: 10.1186/s10194-023-01599-w.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AG09222 in people with Healthy, run by H. Lundbeck A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04976309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.