Clinical trial NCT02741310: Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan
Official title: Phase 1, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effect on Blood Pressure of AMG 334 Given Concomitantly With Subcutaneous Sumatriptan (Imitrex™) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Time-weighted Averages of Mean Arterial Pressure
timeFrame: Days 2 and 5 from predose to 2.5 hours after sumatriptan dosing.
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the first dose of study drug (sumatriptan, placebo or erenumab) until 84 days after the last dose (89 days). Part 1 includes AEs from day 1 to predose on day 4 and Part 2 includes AEs from day 4 through day 89.
measure: Area Under the Concentration-time Curve From Time 0 to 6 Hours for Sumatriptan
timeFrame: Day 2 and day 5 at 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.
measure: Area Under the Concentration-time Curve From Time 0 to Infinity for Sumatriptan
timeFrame: Day 2 and day 5 at 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.
measure: Maximum Observed Plasma Concentration (Cmax) of Sumatriptan
timeFrame: Day 2 and day 5 at predose, 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.
measure: Number of Participants Who Developed Anti-erenumab Antibodies
timeFrame: Baseline and day 89
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: de Hoon J, Van Hecken A, Vandermeulen C, Herbots M, Kubo Y, Lee E, Eisele O, Vargas G, Gabriel K. Phase 1, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the effects of erenumab (AMG 334) and concomitant sumatriptan on blood pressure in healthy volunteers. Cephalalgia. 2019 Jan;39(1):100-110. doi: 10.1177/0333102418776017. Epub 2018 May 21.