Phase 1
Completed N=48
Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients
Source: ClinicalTrials.gov NCT01723514 ↗Enrolled (actual)
48
Serious AEs
4.2%
Results posted
Jan 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 5; 6; 6; 6 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
5; 6; 6; 6; 4; 4 | — |
| PRIMARY Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Developed Anti-erenumab Antibodies |
0; 1; 2; 0; 2; 0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Erenumab |
2.15; 6.26; 13.8; 24.9; 1.76; 11.0 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of Erenumab |
4.0; 4.0; 5.9; 6.9; 6.9; 11 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day) |
34.7; 124; 281; 486; 28.7; 244 | — |
| SECONDARY Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) |
59.3; 342; 848; 1410; 45.0; 773 | — |
| SECONDARY Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow |
9.24; 9.28; 8.92; 8.90; 13.27; 11.08 | < 0.001 sig |
Eligibility Criteria
Inclusion Criteria
Healthy male and female subjects, as well as male or female subjects with migraines between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician;
Exclusion Criteria
- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
Data sourced from ClinicalTrials.gov (NCT01723514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.