Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-22

Study Completion Date

2016-08-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Participants 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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered by intravenous infusion

Sumatriptan

Intervention Type DRUG

Administered by two 6 mg subcutaneous injections 1 hour apart on day 2 and day 5

Erenumab

Participants 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).

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Administered by intravenous infusion

Sumatriptan

Intervention Type DRUG

Administered by two 6 mg subcutaneous injections 1 hour apart on day 2 and day 5

Erenumab

Intervention Type DRUG

Administered by intravenous infusion

Interventions

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Placebo

Administered by intravenous infusion

Intervention Type DRUG

Sumatriptan

Administered by two 6 mg subcutaneous injections 1 hour apart on day 2 and day 5

Intervention Type DRUG

Erenumab

Administered by intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Imitrex™ AMG 334 Aimovig™

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects ≥ 18 to ≤ 55 years old
* Good general health
* Laboratory results within range

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes