The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy adults and migraine patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
48
Research Site
Leuven, Belgium
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life-threatening (places the subject at immediate risk of death) * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Time frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)
Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.
Time frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)
Number of Participants Who Developed Anti-erenumab Antibodies
Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.
Time frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)
Maximum Observed Serum Concentration (Cmax) of Erenumab
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Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
Time to Maximum Observed Concentration (Tmax) of Erenumab
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 57 (assessed from predose to day 225))
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites. Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow. According to the protocol, not all cohorts had dermal blood flow measurements at all time points.
Time frame: Baseline, Days 8, 57, 85, 113, 169 and 197