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Eptinezumab is a preventive treatment for migraine. The drug is made from a process that currently uses yeast cells for production of the drug. The trial researchers want to test whether using a new production cell line to make eptinezumab will affect the way the drug behaves in the body. To do this, the researchers will give a single dose of eptinezumab to healthy participants. Some of the participants will get eptinezumab that has been made from yeast cells. Others will get eptinezumab made with the new cell line.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptinezumab Mammalian Cell Line | Experimental | Participants will receive a single intravenous (IV) infusion of eptinezumab mammalian cell line on Day 1. |
|
| Eptinezumab Yeast Cell Line | Active Comparator | Participants will receive a single IV infusion of eptinezumab yeast cell line on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab Mammalian Cell Line | Drug | Concentrate for solution for IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Eptinezumab Plasma Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf) | Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Extrapolated AUC of Total AUC0-inf (AUC%extr) | Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140 | |
| Maximal Observed Plasma Concentration (Cmax) | Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit, Inc. | Daytona Beach | Florida | 32117 | United States | ||
| Labcorp Clinical Research Unit, Inc. |
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| Eptinezumab Yeast Cell Line | Drug | Concentrate for solution for IV infusion |
|
| Area Under the Plasma Concentration-Time Curve From Zero to Time t (AUC0-t) | Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140 |
| Apparent Terminal Elimination Half-Life (t½) | Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140 |
| Systemic Clearance (CL), Defined as Dose/AUC0-inf | Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140 |
| Apparent Volume of Distribution (Vz) | Day 1 (pre-dose up to 12 hours after the end of the infusion) up to Day 112 (after the end of the infusion), and at the follow-up visit Day 140 |
| Madison |
| Wisconsin |
| 53715 |
| United States |