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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Concentrate for solution for IV infusion
Concentrate for solution for IV infusion
Labcorp Clinical Research Unit, Inc.
Daytona Beach, Florida, United States
Labcorp Clinical Research Unit, Inc.
Madison, Wisconsin, United States
Area Under the Eptinezumab Plasma Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)
Time frame: 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
Percent Extrapolated AUC of Total AUC0-inf (AUC%extr)
Time frame: 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)
Time frame: 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
Area Under the Plasma Concentration-Time Curve From Zero to Time t (AUC0-t)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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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