Phase 1
Completed N=34
Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan
Healthy Subjects
Source: ClinicalTrials.gov NCT02741310 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Time-weighted Averages of Mean Arterial Pressure — 87.40; 87.36 mmHg
Summary
The primary objective of this study was to assess the effects of subcutaneous sumatriptan alone and the effects of a single dose of erenumab (AMG 334) intravenous (IV) and sumatriptan concomitant therapy on resting blood pressure in healthy adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Averages of Mean Arterial Pressure |
87.40; 87.36 | — |
| SECONDARY Number of Participants With Adverse Events |
11; 19; 9; 17; 1; 0 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to 6 Hours for Sumatriptan |
133.33; 130.59 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to Infinity for Sumatriptan |
144.32; 144.81 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Sumatriptan |
83.50; 79.00 | — |
| SECONDARY Number of Participants Who Developed Anti-erenumab Antibodies |
0; 1; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and female subjects ≥ 18 to ≤ 55 years old
- Good general health
- Laboratory results within range
- Other Inclusion Criteria May Apply
Exclusion Criteria
- Female subjects pregnant or breastfeeding
- An unstable medical condition
- History of cancer
- Active liver disease
- Positive Hepatitis B or Hepatitis C
- Unwilling or unable to limit alcohol consumption
- Unable to refrain from strenuous exercise
- Other Exclusion Criteria May Apply
Data sourced from ClinicalTrials.gov (NCT02741310). 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.