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The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ubrogepant with Lu AG09222 | Experimental | Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant. |
|
| Ubrogepant with Placebo | Placebo Comparator | Participants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubrogepant | Drug | Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | Up to 92 Days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity: Area under the plasma concentration curve of ubrogepant from zero to infinity | Predose on Day 1 to Day 12 | |
| Cmax: maximum observed plasma concentration of ubrogepant | Predose on Day 1 to Day 12 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | United States | ||
| NeuroTrials Research |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000615620 | ubrogepant |
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| Lu AG09222 |
| Drug |
Solution for injection/infusion |
|
| Placebo | Drug | Solution for injection/infusion |
|
| tmax: nominal time corresponding to the occurrence of Cmax | Predose on Day 1 to Day 12 |
| t½: apparent elimination half-life of ubrogepant | Predose on Day 1 to Day 12 |
| Oral Clearance (CL/F) of ubrogepant | Predose on Day 1 to Day 12 |
| Apparent volume of distribution (VZ/F) of ubrogepant | Predose on Day 1 to Day 12 |
| Number of participants with anti-drug antibodies for Lu AG09222 | Up to 92 Days |
| Atlanta |
| Georgia |
| 30328 |
| United States |
| Future Search Trials | Austin | Texas | 78731 | United States |
| Elevate Clinical Research | Seabrook | Texas | 77586 | United States |
| D009422 | Nervous System Diseases |