Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan
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
2 other identifiers
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2016
CompletedStudy Start
First participant enrolled
February 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2016
CompletedResults Posted
Study results publicly available
March 5, 2019
CompletedApril 2, 2019
March 1, 2019
6 months
February 19, 2016
May 24, 2018
March 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Time-weighted Averages of Mean Arterial Pressure
Mean arterial pressure (MAP) is the average arterial pressure during a single cardiac cycle. MAP was calculated as diastolic blood pressure (DBP) + 0.33 \* (systolic blood pressure \[SBP\]-DBP). Individual time-weighted average in MAP were calculated as area under the measurement-time curve from predose through 2.5 hours of MAP divided by the time period over which the measurements were made (ie, AUCmap0-2.5 hr /2.5 hours). Data were analyzed using a linear mixed effects regression model with fixed effects for treatment and period and random effect for subject; Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only).
Days 2 and 5 from predose to 2.5 hours after sumatriptan dosing.
Secondary Outcomes (5)
Number of Participants With Adverse Events
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.
Area Under the Concentration-time Curve From Time 0 to 6 Hours for Sumatriptan
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.
Area Under the Concentration-time Curve From Time 0 to Infinity for Sumatriptan
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.
Maximum Observed Plasma Concentration (Cmax) of Sumatriptan
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.
Number of Participants Who Developed Anti-erenumab Antibodies
Baseline and day 89
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous sumatriptan on day 2 (Part 1). After a 2-day washout participants received another placebo IV infusion on day 4 followed by 12 mg subcutaneous sumatriptan on day 5 (Part 2).
Erenumab
EXPERIMENTALParticipants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous sumatriptan on day 2 (Part 1). After a 2-day washout participants received 140 mg erenumab IV infusion on day 4 followed by 12 mg subcutaneous sumatriptan on day 5 (Part 2).
Interventions
Administered by two 6 mg subcutaneous injections 1 hour apart on day 2 and day 5
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects ≥ 18 to ≤ 55 years old
- Good general health
- Laboratory results within range
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (1)
Research Site
Leuven, 3000, Belgium
Related Publications (1)
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.
PMID: 29783863BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2016
First Posted
April 18, 2016
Study Start
February 22, 2016
Primary Completion
August 11, 2016
Study Completion
August 11, 2016
Last Updated
April 2, 2019
Results First Posted
March 5, 2019
Record last verified: 2019-03